{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-26", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "proprietary_name": [ "ScanTarget KIT (DSCTK)", "ScanTarget Bite Cap (DSCTBC2, DSCTBC4)", "Guide Fixture Anchor (DGFAR09, DGFAM09, DGFAN09, DGFAR11, DGFAM11, DGFAN11, DGFAR13, DGFAM13, DGFAN13)", "s-Clean Link Abutment ScanPost (DSSPMC451047, DSSPMC452047, DSSPMC453047, DSSPRC451047S, DSSPRC452047S, DSSPRC453047S)", "Bone Profiler (DBP45, DBP55, DBP65)", "SQ AXEL Guide Step Drill( DSAGSTD4216, DSAGSTD4608, DSAGSTD4610, DSAGSTD4612, DSAGSTD4614, DSAGSTD4616, DSAGSTD5008)", "SQ AXEL Parallel Pin for Drill (DSAPP)", "s-Clean MU Trial Pin (DSMUSTP, DSMUSTPM, DSMUSTPN)", "Guide Bone Anchor (DGBA09, DGBA11, DGBA13)", "SQ AXEL Step Drill (DSASTD2414, DSASTD3807, DSASTD3808, DSASTD3810, DSASTD3812, DSASTD3820, DSASTD4207, DSASTD4208)", "Bone Tack Drill (DBTD08)", "SQ AXEL KIT (DSAMLK, DSAMK, DSANK, DSANLK)", "i-Clean Guide No Mount Driver (DIGNMS, DIGNML, DIGNRS, DIGNRL)", "SQ AXEL Guide Step Drill( DSAGSTD5010, DSAGSTD5012, DSAGSTD5014, DSAGSTD5016)", "I-FIX Angled Mount Adapter (DNAMB, DNAMS, DNAMA)", "Guide Anchor Pin (DGAP14)", "MU Gingival ScanBody (DSMUGSBF)", "Straight Tap Drill (DSTR41, DSTW48)", "Tapered Tap Drill (DTM35, DTM37, DTR41, DTR43, DTW48, DTW51)", "SQ Step Drill (DSQSTD5006, DSQSTD5010, DSQSTD5012, DSQSTD5014)", "SQ Guide No-Mount Driver (DSQGNDNMS, DSQGNDNML, DSQGNDNRS, DSQGNDNRL)", "Bone syringe (DBS-01)", "SQ Parallel Pin for Drill (DSQPP)", "I-FIX Angled Type Impression Coping (DMIC12S, DMIC18S, DMIC23S)", "Spreading adapter (DSA-01)", "Impression Coping Guide Pin (DSGPZS15, DSGPZS19, DSGPZ15, DSGPZ19)", "s-Clean Pick-Up Impression Coping (DSIHZ45SS, DSIHZ45LS, DSIHZ55SS, DSIHZ55LS, DSIHZ65SS, DSIHZ65LS)", "SAVE SEPTUM DRILL KIT (DSSDK)", "Pro KIT (DPK)", "SQ Step Drill (DSQSTD4010, DSQSTD4012, DSQSTD4014, DSQSTD4510, DSQSTD4512, DSQSTD4514)", "i-Clean No-mount Driver (DINDS, DINDL, DMMDI)", "e-Clean Pick-Up Impression Coping Guide Pin (DEGPR10, DEGPR15, DEGPR20, DEGPW10, DEGPW15, DEGPW20)", "Lateral Approach Drill (DLAD-6, DLAD-8)", "s-Clean Transfer Impression Coping (DSITNS40SS, DSITNS40LS, DSITN45SS, DSITN45LS)", "SAVE Twist Drill (DSD5508, DSD5512, DSD6008, DSD6012, DSD6508, DSD6512, DSD7008, DSD7012)", "SAVE Twist Drill (DSD5508TC, DSD5512TC, DSD6008TC, DSD6012TC, DSD6508TC, DSD6512TC, DSD7008TC, DSD7012TC)", "Cortical Perforation bur (DGCPB10L, DGCPB10H)", "Orthodontic Ratchet Driver (DOSRD30)", "e-Clean Fixture Mount (DEFMM, DEFMR, DEFMW)", "Straight Twist Drill (DTD2808TC, DTD2810TC, DTD2812TC, DTD2814TC)", "SINUS CURRETTES (DTOLA-01, DTOLA-02, DTOLA-03, DTOLA-04)", "OneQ Straight Twist Drill (DOTD3607, DOTD3608, DOTD3610, DOTD3612, DOTD3614)", "Bone Ridge Chisel (DBCA15, DBCA25)", "OneQ Countersink (DSOCS37, DSOCS39, DSOCS42, DSOCS47, DSOCS52, DSOCS60, DSOCS70, DSOCS80)", "Diamond Bur (DSSDB20L)", "Simple Guide Plus Straight Drill (DSGPSD2818, DSGPSD2820, DSGPSD2821)", "s-Clean Transfer Impression Coping (DSITNZS40SS, DSITNZS40LS, DSITNZ45SS, DSITNZ45LS)", "I-FIX Point Drill (DIPD)", "SQ Guide No-Mount Driver (DSQGNDRMS, DSQGNDRML, DSQGNDRRS, DSQGNDRRL)", "Aqua Tip (DSSAT, DSSAT31, DSSAT41)", "Lateral Approach Cutter (DLAC-6, DLAC-8)", "i-Clean Excellent Solid Impression Cap (DIESICR, DIESICW)", "Tapered Twist Drill (DTD3708TC, DTD3710TC, DTD3712TC, DTD3714TC)", "Saw Disk (DSDSAW-07, DSDSAW-09, DSDSAW-14)", "Simple Guide Cortical Drill (DSGCD)", "Probe Depth Gauge (DPDG)", "Universal Driver Handle (DGUDH, DOSUH)", "Orthodontic Engine Driver (DOSED22, DOSED32)", "Stopper (DGS03, DGS05, DGS07)", "Drill (DNLBC-2, DNLBC-3, DNLBC-4, DNLBC-5)", "i-Clean Plastic Cylinder (DIOPN, DIOPO)", "Trephine Bur (DSDTRB-04, DSDTRB-05, DSDTRB-06, DSDTRB-07, DSDTRB-08)", "s-Clean HI Bite Coping (DSHISC4540BS, DSHISC4560BS, DSHISC4580BS)", "Crestal Stopper (DSSCS3, DSSCS4, DSSCS5, DSSCS6, DSSCS7, DSSCS3N, DSSCS4N, DSSCS5N, DSSCS6N, DSSCS7N, DSSCS8N)", "i-Clean Octa Pick-Up Impression Coping (DIOINS, DIOIWNS, DIOIOS, DIOIWOS)", "s-Clean Pick-Up Impression Coping (DSIN45SS, DSIN45LS, DSIN55SS, DSIN55LS, DSIN65SS, DSIN65LS)", "Parallel Pin (DPP)", "Straight Twist Drill (DSTD3508, DSTD351C, DSTD3512, DSTD3514)", "s-Clean Pick-Up Impression Coping (DSINZ45LS, DSINZ55SS, DSINZ55LS, DSINZ65SS, DSINZ65LS)", "Bone Trimming Bur (DGBTB50L, DGBTB50H)", "Simple Guide Plus Driver for Ratchet (DSGPRDA)", "s-Clean Transfer Impression Coping (DSITN55SS, DSITN55LS, DSITN65SS, DSITN65LS)", "Mini Twist Drill (DMD13, DMD18, DMD23)", "Tapered Twist Drill (DTD4108TC, DTD4110TC, DTD4112TC, DTD4114TC)", "e-Clean Pick-Up Impression Coping Guide Pin (DEGPM10, DEGPM15, DEGPM20)", "OneQ Straight Twist Drill (DOTD3107, DOTD3108, DOTD3110, DOTD3112, DOTD3114)", "Lateral Approach Reamer (DSSAR60, DSSAR80)", "SQ No-Mount Driver Regular Machine (DSQNDRMS, DSQNDRML)", "Stopper (DNLBC-ST2, DNLBC-ST3, DNLBC-ST4, DNLBC-ST5)", "Marking drill (DMD-3)", "SQ Guide Step Drill (DSQGSTD5508, DSQGSTD5510, DSQGSTD5512, DSQGSTD5514, DSQGSTD5516)", "Tapered Twist Drill (DTD4308TC, DTD4310TC, DTD4312TC, DTD4314TC)", "s-Clean Ratchet Driver (DRMDSS, DRMDSL, DRMDSEL, DSRDSS, DSRDSL)", "Torque Ratchet (DTR, DTR70)", "s-Clean Transfer Impression Coping (DSITHZ55S, DSITHZ55L, DSITHZ65S, DSITHZ65L)", "SAVE BONE EXPANDING KIT (DSBEK)", "SAVE KIT (DSK, DGSK)", "s-Clean OneQ KIT (DSOKIR-1)", "Surgical SQ KIT (DSQKN)", "SAVE Lateral KIT (DSLAK)", "SAVE BONE MULTI KIT (DSBMK)", "SAVE BONE SPREADING KIT (DSBSK)", "SAVE Crestal KIT (DSCAK)", "TREPHINE KIT (DTREK)", "Tapered Twist Drill (DTD3707, DTD3708, DTD3710, DTD3712, DTD3714)", "SAVE Tap Drill (DTW55, DTW60, DTW65, DTW70)", "OneQ Straight Twist Drill (DOTD2807, DOTD2808, DOTD2810, DOTD2812, DOTD2814)", "Simple Guide Intermediate Drill (DSGID2808)", "Hex Driver for Ratchet (DRD09, DRD12S, DRD12L, DRD125S, DRD125L, DRHDL09, DRHDS125, DRHDL125)", "Sensor gauge (DTOCA-SG)", "Lateral Approach Drill (DSSLAD60, DSSLAD80)", "MU Transfer Impression Coping (DMTICS)", "Spreading pin (DSP-01)", "s-Clean Pick-Up Impression Coping (DSIHZS40S, DSIHZS40L, DSIHZ40S, DSIHZ40L, DSIHZ45S, DSIHZ45L)", "Bone Screw Driver (DGBSD)", "Wrench (DSDWRH-00)", "Expander drill (DSDEXP-01, DSDEXP-02, DSDEXP-03, DSDEXP-04, DSDEXP-05)", "SQ Guide Flattener (DSQGFD)", "s-Clean Solid Type PS Abutment (DPSS6515, DPSS6525, DPSS6535, DPSA4515, DPSA4525, DPSA5515, DPSA5525)", "s-Clean Transfer Impression Coping (DSITHZS40S, DSITHZS40L, DSITHZ45S, DSITHZ45L)", "s-Clean Sole Abutment Plastic Coping (DSSP45B, DSSP48B, DSSP55B, DSSP60B, DSSP65B)", "ZMD-1000B Castable", "Straight Twist Drill (DSTD4208, DSTD4210, DSTD4212, DSTD4214)", "Lindemann Drill (DLIND23S, DLIND23L, DSSLD20, DLD-2, DSSLD20N)", "Guide Wheel Drill (DGWPDS, DGWPDL)", "i-Clean Ratchet Driver (DRMDIS, DRMDIL)", "TOP-DRILL (DTD-3, DTD-4)", "s-Clean Pick-Up Impression Coping (DSIH55SS, DSIH55LS, DSIH65SS, DSIH65LS)", "s-Clean Pick-Up Impression Coping (DSINZS40S, DSINZS40L, DSINZ40S, DSINZ40L, DSINZ45S)", "i-Clean OneQ KIT (DIOK)", "Point Drill (DPD)", "Straight Twist Drill (DTD2808, DTD2810, DTD2812, DTD2814)", "Simple Guide Plus Straight Drill (DSGPSD3518, DSGPSD3520, DSGPSD3521)", "Simple Guide Starter Drill (DSGSD2308)", "OneQ Straight Twist Drill (DOTD2507, DOTD2508, DOTD2510, DOTD2512, DOTD2514)", "SQ Guide Initial Drill (DSQGSTD5010, DSQGSTD5012, DSQGSTD5014, DSQGSTD5016)", "SQ Step Drill (DSQSTD2814, DSQSTD3507, DSQSTD3508, DSQSTD4006, DSQSTD4007, DSQSTD4008, DSQSTD4507,DSQSTD4508,DSQSTD2820)", "SQ Straight Drill (DSQSD2206, DSQSD2207, DSQSD2208, DSQSD2210, DSQSD2212, DSQSD2214, DSQSD2220)", "Stopper (DS55-2, DS55-3, DS55-4, DS60-2, DS60-3, DS60-4)", "s-Clean Transfer Impression Coping (DSITH55SS, DSITH55LS, DSITH65SS, DSITH65LS)", "SQ No-Mount Driver Regular Ratchet (DSQNDRRS, DSQNDRRL)", "Simple Guide Plus Driver for Machine (DSGPDA)", "Ratchet Wrench (DRW)", "Depth Gauge (DDG22, DDG28)", "Guide Wheel Initial Drill (DGWID20)", "Bone Chip (DGBC50)", "s-Clean OneQ No-mount Driver (DSNDSS, DSNDSL)", "Straight Twist Drill (DSTD4208TC, DSTD4210TC, DSTD4212TC, DSTD4214TC)", "Impression Coping Guide Pin (DSTSSZ, DSTSLZ, DSTSZ, DSTLZ)", "Bone pusher (DNLBC-BP)", "e-Clean Fixture Short Mount Screw (DESMS, DESRS, DESWS)", "Stopper Support (DSS55, DSS60)", "e-Clean Transfer Impression Guide Pin (DETSM, DETSR, DETSW)", "s-Clean Pick-Up Impression Coping (DSINS40SS, DSINS40LS, DSIN40SS, DSIN40LS)", "Lateral Approach Reamer (DLAR-R8, DLAR-F8)", "Wrench adapter (DWA, DWA-01)", "Titanium Suction Tip (DSSST)", "Guide Punch (DSDGTS-40, DSDGTS-50)", "Lateral Stopper (DSSLS05, DSSLS10, DSSLS15, DSSLS20, DSSLS25, DSSLS30)", "Straight Twist Drill (DSTD3508TC, DSTD3510TC, DSTD3512TC, DSTD3514TC)", "s-Clean Pick-Up Impression Coping (DSIHS40SS, DSIHS40LS, DSIH40SS, DSIH40LS, DSIH45SS, DSIH45LS)", "e-Clean tapered KIT (DEK, DGEK)", "s-Clean Transfer Impression Coping(DSITNZ55S, DSITNZ55L, DSITNZ65S, DSITNZ65L)", "Mini KIT (DMK)", "s-Clean Transfer Impression Coping (DSITNZ55SS, DSITNZ55LS, DSITNZ65SS, DSITNZ65LS)", "I-FIX Angled Type Mount Adapter Screw (DMAMS)", "s-Clean Pick-Up Impression Coping Guide Pin (DSGPS10, DSGPS14, DSGPS15, DSGPS19)", "Straight Mini KIT (DSMK)", "i-Clean OneQ KIT (DIOKU)", "SAVE BASIC KIT (DSBISK)", "MU Lab Analog (DMLA)", "SQ Guide KIT (DSQGK, DSQGKA)", "SAVE GBR KIT (DGKT)", "SAVE BONE TRIMMING KIT (DSBTK)", "SQ Guide Countersink (DSQGCS55)", "Tapered Twist Drill (DTD4807, DTD4808, DTD4810, DTD4812, DTD4814)", "I-FIX Fixture Machine Driver (DMML, DMMS)", "Orthodontic Handle Driver (DOSHD60)", "s-Clean MU Angled Abutment Guide (DSMUAG)", "s-Clean Solid Type PS Abutment (DPSS4515, DPSS4525, DPSS4535, DPSS5515, DPSS5525, DPSS5535)", "s-Clean Impression Positioning Cylinder (DSIPC45, DSIPC48, DSIPC55, DSIPC60, DSIPC65)", "Parallel Pin for Drill (DPPD)", "ZMD-1000B CLEAR-SG", "Octa Abutment Lab Analog (DIOLA, DIOLAW)", "s-Clean Sole Abutment Plastic Coping (DSSP45S, DSSP48S, DSSP55S, DSSP60S, DSSP65S)", "s-Clean Pick-Up Impression Coping (DSINZ45L, DSINZ55S, DSINZ55L, DSINZ65S, DSINZ65L)", "s-Clean Sole Abutment Lab Analog (DSSLA554, DSSLA55, DSSLA557, DSSLA60L, DSSLA654, DSSLA65, DSSLA657)", "s-Clean MU Transfer Impression Coping (DSMUTIC, DSMUTICSS)", "i-Clean Solid Positioning Cylinder (DISIPCR, DISIPCW, DISIPCW65)", "e-Clean Transfer Impression Coping (DETIR60NS, DETIR60HS, DETIW60NS, DETIW60HS)", "e-Clean Plastic UCLA Abutment (DEPMH, DEPMN, DEPRH, DEPRN, DEPWH, DEPWN)", "s-Clean Pick-Up Impression Coping Guide Pin (DSGP11, DSGP15, DSGP19)", "Simple Guide Plus Straight Drill (DSGPSD2024, DSGPSD2824)", "s-Clean ScanBody (DSSBMESS, DSSBMSS, DSSBMLS, DSSBMELS)", "s-Clean OneQ SMART KIT (DSOSK)", "SPLIT MASTER KIT (DSPLMK)", "I-FIX Post Type Lab Analog (DMPL)", "Carbide Bur (DSSCB14L, DSSCB18L)", "e-Clean Pick-Up Impression Coping (DEIM40HS, DEIR50HS, DEIR60HS, DEIW60HS, DEIM40NS, DEIR50NS, DEIR60NS, DEIW60NS)", "i-Clean Solid Type PS Abutment (DPIS40, DPIS55, DPIS70, DPIA15, DPIA25)", "s-Clean ScanBody set (DSSBNESS, DSSBNSS, DSSBNLS, DSSBNELS, DSSBRESS, DSSBRSS, DSSBRLS, DSSBRELS)", "e-Clean Fixture Short Mount (DEFMSM, DEFMSR, DEFMSW)", "s-Clean Digital Lab Analog (DSDLANS, DSDLAMS, DSDLARS)", "s-Clean Impression Positioning Cylinder (DSIPC554, DSIPC555, DSIPC557)", "SINUS KIT (DSINK)", "s-Clean Impression Positioning Cylinder (DSIPC654, DSIPC655, DSIPC657)", "BONE PROFILER KIT (DBPK)", "Tapered Twist Drill (DTD3508TC, DTD3510TC, DTD3512TC, DTD3514TC)", "s-Clean Impression Positioning Cylinder (DSIPC454, DSIPC455, DSIPC457)", "SQ Step Drill (DSQSTD5007, DSQSTD5008, DSQSTD3510, DSQSTD3512, DSQSTD3514)", "s-Clean MU Straight Abutment Digital Lap (DSMUSDL)", "Mount Driver for Ratchet (DRHDS24, DRHDL24, DRHDS30, DRHDL30)", "s-Clean Sole Abutment Lab Analog (DSSLAS404, DSSLAS405, DSSLAS407)", "Handpiece condenser (DSDADP-01)", "Reamer (DSD-RM23, DSD-RM28, DSD-RM33, DSD-RM37, DSSR28N, DSSR31N, DSSR36N, DSSR41N)", "ZMD-1000B Model", "s-Clean No-Mount Driver (DSNDMS, DSNDML)", "SQ Guide Initial Drill (DSQGSTD4510, DSQGSTD4512, DSQGSTD4514, DSQGSTD4516)", "Simple Guide Plus Straight Drill (DSGPSD4318, DSGPSD4320, DSGPSD4321)", "Crestal Stopper (DSSCS8, DSSCS9, DSSCS10, DSSCS11, DSSCS12)", "I-FIX Angled Type Mount Adapter (DMAMA)", "Bone Tack Removal Tip (DGBTRT)", "Mini Depth Gauge (DMDP)", "Stopper (DST-08, DST-09, DST-10, DST-11, DST-12)", "s-Clean Pick-Up Impression Coping (DSINMZ45LS, DSINMZ55SS, DSINMZ55LS)", "s-Clean Plastic UCLA Abutment (DSPCH, DSPCN, DSPCHS, DSPCNS)", "i-Clean Excellent Solid Positioning Cylinder (DIESIPCR, DIESIPCW)", "i-Clean Shoulder Analog (DIISAR, DIISAW65)", "SQ Straight Twist Drill (DSQTD2807, DSQTD2808, DSQTD2810, DSQTD2812, DSQTD2814)", "Simple Guide Plus Reamer Drill (DSGPR45, DSGPR53)", "SQ Guide Profile (DSQGPD35, DSQGPD40)", "s-Clean HI Bite Coping (DSHISC5520S, DSHISC5530S, DSHISC5540S, DSHISC5560S, DSHISC5580S)", "i-Clean Octa Pick-Up Impression Coping Guide Pin (DIOGP, DIOGP10, DIOGP15, DIOGP20)", "SQ Lindemann Drill (DLINDST23)", "i-Clean Solid Impression Cap (DISICR, DISICW, DISICW65", "Bone Tack Driver Straight (DGBTDS)", "BMS Chisel (DSCL-05)", "Depth Gauge (DSSDG)", "s-Clean ScanBody (DSSBMES, DSSBMS, DSSBML, DSSBMEL)", "SMART KIT (DNSK)", "Simple Guide KIT (DSGK)", "Tapered Twist Drill (DTD4307, DTD4308, DTD4310, DTD4312, DTD4314)", "Straight Twist Drill (DTD2208TC, DTD2210TC, DTD2212TC, DTD2214TC)", "OneQ Straight Twist Drill (DOTD4207, DOTD4208, DOTD4210, DOTD4212, DOTD4214)", "SQ Guide Initial Drill (DSQGSTD2208, DSQGSTD2210, DSQGSTD2212, DSQGSTD2214, DSQGSTD2216)", "Bone Screw Driver Tip for Hand Piece (DGBSDTH)", "s-Clean ScanBody Screw(DSSBSS, DSSBS)", "Bone packer (DTOCA-BP)", "s-Clean Impression Positioning Cylinder (DSIPCS404, DSIPCS405, DSIPCS407)", "s-Clean Pick-Up Impression Coping (DSINZS40SS, DSINZS40LS, DSINZ40SS, DSINZ40LS, DSINZ45SS)", "i-Clean Fixture Lab Analog (DILA, DILAW)", "SQ SINUS Guide SINUS Drill (DSQSGSD4107, DSQSGSD4111)", "s-Clean OneQ KIT (DSOK)", "MU Polishing Protector (DMPP)", "s-Clean MU Pick-up Impression Coping Screw (DSMUPICS)", "Straight Twist Drill (DTD2208, DTD2210, DTD2212, DTD2214)", "i-Clean Solid Abutment Driver (DSAD, DSADS, DSADL)", "Mount Driver for Machine (DMHD24, DMHD30, DMHDS24)", "i-Clean Transfer Impression Coping (DITIRS, DITIWS, DITINS, DITIWNS)", "s-Clean HI Bite Coping (DSHISC4520S, DSHISC4530S, DSHISC4540S, DSHISC4560S, DSHISC4580S)", "s-Clean Transfer Impression Coping (DSITHZS40SS, DSITHZS40LS, DSITHZ45SS, DSITHZ45LS)", "s-Clean Ratchet Driver Square Narrow (DSRDNS, DSRDNL, DSRDNEL)", "SQ SINUS Guide Depth Gauge (DSQSGDG)", "Straight KIT (DCSK)", "s-Clean Pick-Up Impression Coping (DSIHMZ45LS, DSIHMZ55SS, DSIHMZ55LS)", "DOS KIT (DOSK)", "Tissue Punch KIT (DTPK)", "s-Clean Pick-Up Impression Coping (DSIHMZ40SS, DSIHMZ40LS, DSIHMZ45SS)", "SQ Guide Initial Drill (DSQGSTD4010, DSQGSTD4012, DSQGSTD4014, DSQGSTD4016)", "SQ Countersink (DSQCS35, DSQCS40, DSQCS45, DSQCS50, DSQCS55, DSQCSS60)", "Guide Drill (DGD-20)", "SQ SHORT&WIDE KIT (DSQSWK)", "Diamond reamer (DTOCA-DR20, DTOCA-DR28, DTOCA-DR33)", "s-Clean OneQ KIT (DSOKU)", "Tapered Twist Drill (DTD3508, DTD3510, DTD3512, DTD3514)", "SQ KIT (DSQK, DSQAK)", "OneQ Straight Twist Drill (DOTD5307, DOTD5308, DOTD5310, DOTD5312)", "SQ Guide Initial Drill (DSQGSTD3510, DSQGSTD3512, DSQGSTD3514, DSQGSTD3516)", "Pilot Drill (DGPD12)", "Simple Guide Plus Initial Drill (DSGPID)", "Guide Drill (DSDGDL-02)", "Bone Tack Driver Curved (DGBTDC)", "i-Clean Octa Transfer Impression Coping (DIOTIS, DIOTIWNS, DIOTIOS, DIOTIWOS)", "i-Clean Excellent Abutment Driver (DESAD)", "Drill Extension (DDE)", "Path Guide Pin for SQ Fixture (DSQPGPS, DSQPGPR)", "Guide Wheel Guide Pole (DGWGP, DGWGPL)", "SAVE 02 (DSSS02)", "Trephine drill (DTB-3)", "Drilling Guide Wheel (DGW6, DGW7, DGW8, DGW9, DGW10, DGW12)", "s-Clean Tapered Countersink (DSTCS37, DSTCS41, DSTCS43, DSTCS48)", "SQ Guide Initial Drill (DSQGID22, DSQGID35)", "O-Ring Abutment Driver (DORADS, DORADL)", "Simple Guide Plus Sleeve (DSGPS)", "Bone packer (DSSBP, DSSBPN)", "Tapered Twist Drill (DTD4107, DTD4108, DTD4110, DTD4112, DTD4114)", "Expander drill (DSDEXPM-02, DSDEXPM-03, DSDEXPM-04, DSDEXPM-05)", "SAVE TORQUE (DSTDK)", "Simple Guide Plus Sleeve Connector (DSGPSC)", "i-Clean Shoulder Analog Pin (DISAPR)", "SQ Guide Sleeve (DSQGS35, DSQGS45, DSQGS45C)", "s-Clean Transfer Impression Coping (DSITNZS40S, DSITNZS40L, DSITNZ45S, DSITNZ45L)", "I-FIX Fixture Ratchet Driver (DMRL, DMRS)", "s-Clean Transfer Impression Coping (DSITHS40SS, DSITHS40LS, DSITH45SS, DSITH45LS)", "Guide Wheel Guide Pin (DGWGP6, DGWGP7, DGWGP8, DGWGP9, DGWGP10, DGWGP12)", "s-Clean Pick-Up Impression Coping (DSIHZ55S, DSIHZ55L, DSIHZ65S, DSIHZ65L)", "s-Clean Fixture Lab Analog (DSCLA, DSCALS)", "s-Clean MU Transfer Impression coping Screw (DSMUTICS)", "Path Guide Pin for SQ Fixture (DSQPGPM)", "Tapered Twist Drill (DTD5108TC, DTD5110TC, DTD5112TC, DTD5114TC)", "s-Clean Transfer Impression Coping (DSITH65S, DSITH65L, DSITNS40S, DSITNS40L)", "s-Clean Transfer Impression Coping (DSITNMZ45LS, DSITNMZ55SS, DSITNMZ55LS)", "OneQ Straight Twist Drill (DOTD6407, DOTD6408, DOTD6410, DOTD6412)", "Simple Guide Plus Profiler Drill (DSGPPD)", "SQ Guide Initial Drill (DSQGSTD3508, DSQGSTD4008, DSQGSTD4508, DSQGSTD5008)", "i, s-Clean tapered KIT (DIK, DGIK, DIKO)", "OneQ Smart KIT (DIOSK)", "Simple Guide Plus Straight Drill (DSGPSD2016, DSGPSD2018, DSGPSD2019)", "Depth Gauge (DGAG-08, DSSDGN)", "SAVE 01 (DSSS01)", "DENTIS GUIDE Anchor Screw (DGAS18)", "Path Guide Pin for s-Clean Fixture (DSPGPS, DSPGPR)", "Tapered Twist Drill (DTD5108, DTD5110, DTD5112, DTD5114)", "Simple Guide Pilot Drill (DSGPD2210, DSGPD2212,DSGPD2214)", "MU Pick-Up Impression Coping (DMPUICS)", "Position Guide (DPG07)", "Bone Well (DSSBW)", "s-Clean HI Bite Coping (DSHISC6520S, DSHISC6530S, DSHISC6540S, DSHISC6560S, DSHISC6580S)", "Top Bur (DH-2, DH-3, DL-2, DL-3)", "Mini Twist Drill (DMD13TC, DMD18TC, DMD23TC)", "SAVE BONE CHIP DRILL KIT (DSBDK)", "SAVE RIDGE KIT (DSRK)", "Wall Expander (DSSWE)", "SQ Guide Tissue Punch (DSGPTP)", "s-Clean Pick-Up Impression Coping (DSIHZS40SS, DSIHZS40LS, DSIHZ40SS, DSIHZ40LS)", "Tapered Twist Drill (DTD4808TC, DTD4810TC, DTD4812TC, DTD4814TC)", "DENTIS GUIDE Anchor Twist Drill (DGATD)", "Guide Wheel KIT (DGWK)", "Reamer (DSSR28, DSSR31, DSSR36, DSSR41)", "OneQ Surgical Tap (DSOFST30, DSOFST33, DSOFST37, DSOFST42, DSOFST47, DSOFST52, DSOFST60, DSOFST70, DSOFST80)", "Octa Abutment Driver (DOADS, DOADL)", "s-Clean Transfer Impression Coping (DSITHMZ40SS, DSITHMZ40LS, DSITHMZ45SS)", "s-Clean ScanBody (DSSBNES, DSSBNS, DSSBNL, DSSBNEL, DSSBRES, DSSBRS, DSSBRL, DSSBREL)", "s-Clean MU Straight Abutment Guide (DSMUSG)", "Stopper (DST-03, DST-04, DST-05, DST-06, DST-07)", "s-Clean Transfer Impression Coping (DSITHZ55SS, DSITHZ55LS, DSITHZ65SS, DSITHZ65LS)", "s-Clean Transfer Impression Coping (DSITN45S, DSITN45L, DSITN55S, DSITN55L, DSITN65S, DSITN65L)", "SQ Guide Countersink (DSQGCS35, DSQGCS40, DSQGCS45, DSQGCS50)", "i-Clean Transfer Impression Guide Pin (DITL, DITS)", "Restorative KIT (DRK)", "i-Clean Pick-Up Impression Coping (DIPINS, DIPIRS, DIPIS60S, DIPIWS, DIPIWNS)", "Simple Guide Sleeve (DSGS)", "Tissue Punch (DSQGTP, DSDTIS-30, DSDTIS-35, DSDTIS-40, DSDTIS-45, DSDTIS-50)", "SAVE 03 (DSSS03, DSSS03N)", "SAVE SINUS KIT (DSSK)", "Hex Driver for Ratchet (DRHDL12)", "I-FIX O-Ring Type Lab Analog (DMOL)", "O-Ring Abutment Lab Analog (DOLA)", "Simple Guide Plus KIT (DSGPK)", "Combined KIT (DCK, DGCK)", "GT SMART KIT (DGNSK, DGENSK)", "s-Clean Ratchet Driver Square Mini (DSRDMS, DSRDML, DSRDMEL)", "s-Clean Digital Lab Analog (DSDLAN, DSDLAM, DSDLAR)", "i-Clean ScanBody (DISBS, DISBL, DISBWS, DISBWL)", "s-Clean Multi Use Coping Bite Cap (DSHIBCS, DSHIBCL)", "SQ Countersink Short (DSQCSS50)", "Surgical SQ KIT (DSQKF, DSQKN-1)", "Hex Driver for Ratchet (DRHDES125, DRHD3512)", "s-Clean Ratchet Driver (DRMDSMS, DRMDSML,DRMDSMEL)", "s-Clean Sole Abutment Lab Analog (DSSLA454, DSSLA45, DSSLA457, DSSLA48L)", "i-Clean Solid Abutment Plastic Coping (DISPB, DISWPB, DISPS, DISWPS)", "s-Clean Multi Use Coping (DSMUC6524S, DSMUC6534S, DSMUC6544S, DSMUC6564S, DSMUC6584S)", "SQ Countersink Wide (DSQCSW60, DSQCSW70, DSQCSW80)", "s-Clean MU Straight Abutment Driver (DSMUSD)", "e-Clean Transfer Impression Coping (DETIM40NS, DETIM40HS, DETIR50NS, DETIR50HS)", "i-Clean Excellent Solid Abutment Lab Analog (DIESLA30, DIESLA40, DIESLA55, DIESLA70)", "i-Clean Solid Abutment Lab Analog (DISLAW40, DISLAW55, DISLAW70)", "s-Clean MU Pick-up Impression Coping (DSMUPIC, DSMUPICSS)", "s-Clean Multi Use Coping (DSMUC4524S, DSMUC4534S, DSMUC4544S, DSMUC4564S, DSMUC4584S)", "s-Clean Transfer Impression Coping (DSITHS40S, DSITHS40L, DSITH45S, DSITH45L, DSITH55S, DSITH55L)", "SQ SINUS Guide Stopper (DSQSGS00, DSQSGS01, DSQSGS02, DSQSGS03)", "s-Clean ScanBody Screw (DSSBSM)", "i-Clean SAVE Fixture Lab Analog (DILAS)", "e-Clean Fixture Lab Analog (DELAM, DELAR, DELAW)", "I-FIX Angled Type Lab Analog (DMAL)", "Simple Guide Analog Positioner (DSGAP, DSGAPS)", "Step Drill (DSQSTD5507, DSQSTD5508, DSQSTD5510, DSQSTD5512, DSQSTD5514)", "s-Clean MU Angled Abutment Digital Lap (DSMUADL17, DSMUADL30)", "s-Clean Ratchet Driver Square Regular (DSRDRS, DSRDRL, DSRDREL)", "SQ SINUS Guide SINUS Drill (DSQSGSD3107, DSQSGSD3111)", "i-Clean Solid Abutment Lab Analog (DISLA30, DISLA40, DISLA55, DISLA70)", "s-Clean Multi Use Coping Screw (DSHHS01, DSHHS02, DSHHS03, DSHHS04, DSHHS06, DSHHS08)", "s-Clean Lab Analog Screw (DDLAS)", "s-Clean Transfer Impression Coping (DSITNMZ40SS, DSITNMZ40LS, DSITNMZ45SS)", "SQ SINUS Guide Stopper (DSQSGS04, DSQSGS05, DSQSGS06)", "SQ Guide No-Mount Driver (DSQGNDMMS, DSQGNDMML, DSQGNDMRS, DSQGNDMRL)", "s-Clean Multi Use Coping Transfer Impression Cap (DSHITIC)", "s-Clean Lab Analog (DSCLAM, DSSLAM405, DSSLAM407)", "SQ SINUS Guide SINUS Drill (DSQSGSD2807, DSQSGSD2811)", "s-Clean Transfer Impression Coping (DSITHMZ45LS, DSITHMZ55SS, DSITHMZ55LS)", "SQ Guide Lindemann Drill (DSQGLD2204, DSQGLD2206, DSQGLD2210)", "SQ SINUS Guide Initial Drill (DSQSGID2206, DSQSGID2210)", "SQ SINUS Guide Initial Drill (DSQSGID3006, DSQSGID3010)", "s-Clean Pick-Up Impression Coping (DSINMZ40SS, DSINMZ40LS, DSINMZ45SS)", "SQ SINUS Guide SINUS Drill (DSQSGSD3607, DSQSGSD3611)", "SQ SINUS Guide KIT (DSQSGK)", "i-Clean ScanBody (DISBSS, DISBLS, DISBWSS, DISBWLS)", "Smart Drill (DSD3310TC, DSD3710TC, DSD3910TC, DSD4310TC)", "s-Clean Plastic UCLA Abutment (DSPCHM, DSPCNM, DSPCHMS, DSPCNMS)", "s-Clean Multi Use Coping (DSMUC5524S, DSMUC5534S, DSMUC5544S, DSMUC5564S, DSMUC5584S)", "Drill Holder (DDH39, DDH43, DDH53, DDH53L)", "Hex Driver for Machine (DMDH125L, DMDH125S, DMDH12S)", "SQ Mini Guide Long Drill (DSQMGLD)", "s-Clean Multi Use Coping Screw (DSMUCSN02 DSMUCSN03 DSMUCSN04 DSMUCSN06 DSMUCSN08)", "s-Clean Multi Use Coping Driver (DHIHS, DHIHL)", "SQ Mini Guide Countersink (DSQMGCS3935, DSQMGCS4340)", "SQ Mini Guide No Mount Driver (DSQMGNDMRS43.DSQMGNDMRL43)", "MU ScanBody Screw (DSMUSS)", "SQ Mini Guide No Mount Driver (DSQMGNDMMS39, DSQMGNDMML39)", "SQ Mini Guide Initial Drill (DSQMGID4304, DSQMGID4306, DSQMGID4310)", "s-Clean MU ScanBody (DSMUSBS, DSMUSBL, DSMUSBSS, DSMUSBLS, DSMUSBLF, DSMUSBLFS)", "I-FIX Post Type Temporary Cap (DMPTC)", "Smart Drill (DSD3314TC, DSD3714TC, DSD3914TC, DSD4314TC)", "Tissue Punch (DMTP30, DMTP40, DMTP50, DMTP55, DMTP60)", "s-Clean Sole Abutment Plastic Coping (DSSAP55S, DSSAP55B, DSSAP65S, DSSAP65B)", "SQ Mini Guide Sleeve (DSQMGS4307, DSQMGS4305, DSQMGS3907, DSQMGS3905)", "SQ Mini Guide Tissue Punch (DSQMGTP39, DSQMGTP43)", "s-Clean Fixture Lab Analog (DSCLA1)", "SQ Mini Guide Flattener (DSQMGFD39, DSQMGFD43)", "MU Plastic Cylinder (DMPCS)", "SQ Mini Guide No Mount Driver (DSQMGNDMMS43, DSQMGNDMML43)", "ScanBody KIT (DSBK)", "i-Clean Plastic Cylinder (DIOPWO, DIOPWN)", "Simple Guide KIT (DSGKU)", "MU Reverse Screw (DSMURS)", "s-Clean ScanBody (DSSBRLFS, DSSBMLFS, DSSBNLFS)", "MU Reverse ScanBody (DSMURSBS, DSMURSB)", "s-Clean No-mount Driver (DSNDS, DSNDL, DMMDS)", "Surgical SQ KIT (DSQKAU)", "I-FIX Angled Type ScanBody Screw (DFSBS)", "SQ Mini Guide Step Drill (DSQMGSTD392208, DSQMGSTD392210, DSQMGSTD392212, DSQMGSTD392214, DSQMGSTD392216)", "ScanBody Screw Bar (DSSBSBQ, DSSBSBQ4, DSSBSBH, DSSBSBH4, DSSBSBC4, DSSBSBT4)", "SQ Step Drill (DSQSTD3520, DSQSTD4020, DSQSTD4520, DSQSTD5020, DSQSTD5520)", "O-Ring Abutment O-Ring (DOAO100)", "SQ Mini Guide Step Drill (DSQMGSTD433508, DSQMGSTD433510, DSQMGSTD433512, DSQMGSTD433514, DSQMGSTD433516)", "SQ Mini Guide Initial Drill (DSQMGID3904, DSQMGID3906, DSQMGID3910)", "Straight Pilot Drill (DSPD28, DSPD35, DSPD42, DSPD47, DSPD57)", "SQ Guide Long Drill (DSQGLD, DSQGLD4, DSQGLD6, DSQGLD10)", "s-Clean Sole Abutment Plastic Coping (DSSASP40S, DSSASP40B, DSSAP45S, DSSAP45B)", "s-Clean Multi Use Coping (DSMUCN4524S DSMUCN4534S DSMUCN4544S DSMUCN4564S DSMUCN4584S)", "SQ Mini Guide No Mount Driver (DSQMGNDMRS39, DSQMGNDMRL39)", "SQ Mini Guide Step Drill (DSQMGSTD434008, DSQMGSTD434010, DSQMGSTD434012, DSQMGSTD434014, DSQMGSTD434016)", "I-FIX Post Type Impression Cap (DMPIC)", "Surgical SQ KIT (DSQKA)", "SQ Mini Guide KIT (DSQMGK, DSQMGKO)", "SQ AXEL Countersink (DSACS50, DSACS38, DSACS42, DSACS46)", "SQ Mini Guide Step Drill (DSQMGSTD393508, DSQMGSTD393510, DSQMGSTD393512, DSQMGSTD393514, DSQMGSTD393516)", "Hex Driver for Ratchet (DRHDSO, DRHDLO)", "SQ Mini Guide Profiler (DSQMGPD39, DSQMGPD43)", "Hex Driver for Ratchet (DRHDS12, DRHD2312, DRHD23125, DRHD35125)", "MU Abutment Driver (DMAD)", "s-Clean ScanBody (DSSBRLF, DSSBMLF, DSSBNLF)", "s-Clean MU Angled Trial Pin (DSMUATP17, DSMUATP30, DSMUATPM17, DSMUATPM30, DSMUATPN17, DSMUATPN30)", "s-Clean Multi Use Coping (DSMUCN4524 DSMUCN4534 DSMUCN4544 DSMUCN4564 DSMUCN4584)", "SQ AXEL Guide Step Drill (DSAGSTD2208, DSAGSTD2210, DSAGSTD2212, DSAGSTD2214, DSAGSTD2216, DSAGSTD3808, DSAGSTD3810)", "s-Clean MU Digital Lab (DSMUDL, DSMUDLS)", "AXEL AOX KIT (DSAAONK, DSAAOMK)", "SQ AXEL Step Drill (DSASTD5007, DSASTD5008, DSASTD5010, DSASTD5012, DSASTD5020, DSASTD2420)", "i-Clean Neck Profiler (DINP48, DINP65)", "I-FIX Bone Profiler (DBPI40)", "s-Clean Link Abutment ScanPost (DSSPRC451047, DSSPRC452047, DSSPRC453047, DSSPNC451047, DSSPNC452047, DSSPNC453047)", "SQ Step Drill (DSQSTD5007W, DSQSTD5008W)", "SQ Guide Profiler Drill (DSQGPDM)", "SQ AXEL Step Drill (DSASTD4210, DSASTD4212, DSASTD4220, DSASTD4607, DSASTD4608, DSASTD4610, DSASTD4612, DSASTD4620)", "SAVE CRESTAL SINUS KIT (DSCSK)", "SQ AXEL Guide Step Drill (DSAGSTD3812, DSAGSTD3814, DSAGSTD3816, DSAGSTD4208, DSAGSTD4210, DSAGSTD4212, DSAGSTD4214)", "SQ AXEL Step Drill (DSASTD5014, DSASTD4614, DSASTD4214, DSASTD3814, DSASTD5412)", "Digital Lab Analog Screw (DDLAWS)", "s-Clean MU Parallel Pin (DSMUPPA17, DSMUPPA30)", "SQ AXEL Guide Countersink (DSAGCS38, DSAGCS42, DSAGCS46, DSAGCS50)", "Osteotome (DSSO35R, DSSO42R, DSSO35S, DSSO42S)", "i-Clean Digital Lab Analog (DIDLAR, DIDLARS, DIDLAW, DIDLAWS)", "SQ AXEL Guide KIT (DSAGMK, DSAGNK)", "Bone Profiler Base (DBPBM, DBPBR, DBPBN)", "ScanTarget (DSCTS, DSCTM, DSCTL)", "I-FIX Angled Type ScanBody (DFASBLS, DFASBSS, DFASBL, DFASBS)", "s-Clean Link Abutment ScanPost (DSSPNC451047S, DSSPNC452047S, DSSPNC453047S, DSSPMC451047S, DSSPMC452047S,DSSPMC453047S)" ], "establishment_type": [ "Manufacture Medical Device" ], "registration": { "registration_number": "3036190511", "fei_number": "3036190511", "status_code": "1", "initial_importer_flag": "N", "reg_expiry_date_year": "2027", "name": "Dentis Co.,Ltd", "address_line_1": "87, Yuram-ro", "address_line_2": "", "city": "Dong-gu Daegu", "state_code": "", "iso_country_code": "KR", "zip_code": "", "postal_code": "41059", "us_agent": { "name": "April Lee", "business_name": "", "bus_phone_area_code": "909", "bus_phone_num": "2749971", "bus_phone_extn": "", "fax_area_code": "", "fax_num": "", "email_address": "withus6664@gmail.com", "address_line_1": "106 Superior", "address_line_2": "", "city": "Irvine", "state_code": "CA", "iso_country_code": "US", "zip_code": "92620", "postal_code": "" }, "owner_operator": { "firm_name": "Dentis Co., Ltd.", "owner_operator_number": "10025697", "official_correspondent": {}, "contact_address": { "address_1": "99, Seongseoseo-ro, Dalseo-gu", "address_2": "", "city": "Daegu", "state_code": "KR-27", "state_province": "", "iso_country_code": "KR", "postal_code": "42718" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "NDP", "created_date": "2009-07-14", "owner_operator_number": "10025697", "exempt": "", "openfda": { "device_name": "Accessories, Implant, Dental, Endosseous", "medical_specialty_description": "Dental", "regulation_number": "872.3980", "device_class": "1" } } ] } ] }