{
  "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": "2026-10-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 85
    }
  },
  "results": [
    {
      "proprietary_name": [
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, C3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, B2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, C2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, D3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach White",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, A1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, D3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A3.5",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, Bleach White",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD, C3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD 3 mmP, A3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, A4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, B4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, D3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, A3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, C1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, C4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, D2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, B1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, C2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, B3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A3.5",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD X 4.5 mmP, Bleach3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, B3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, D2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, A3.5",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, C4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, C3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, D4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, B2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, Bleach White",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, Bleach1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD X 4.5 mmP, Bleach White",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, Bleach1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, C2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, Bleach3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm x 3 mmP, D2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, A3.5",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, A3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, Bleach1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, A3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, A4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, D3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, Bleach White",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, Bleach White",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, Bleach3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, B1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, B4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, B3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, C2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, B2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, B1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A3.5",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, C1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, C1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, A2",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, B3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, B4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, B4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, B1",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, D3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, D4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, D4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mmD x 4.5 mmP, D3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, Bleach1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A4",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, A1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, C1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 7 mmD, D2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, A2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, C3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, D4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, A2",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, C4",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mmD x 3 mmP, C1",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 5 mmD, Bleach3",
        "BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, Bleach3",
        "BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mmD x 3.5 mmP, A3.5"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3011649314",
        "fei_number": "3011649314",
        "status_code": "1",
        "initial_importer_flag": "Y",
        "reg_expiry_date_year": "2026",
        "name": "PRISMATIK DENTALCRAFT, INC.",
        "address_line_1": "2144 Michelson Drive",
        "address_line_2": "",
        "city": "Irvine",
        "state_code": "CA",
        "iso_country_code": "US",
        "zip_code": "92612",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "PRISMATIK DENTALCRAFT, INC.",
          "owner_operator_number": "10043585",
          "official_correspondent": {
            "first_name": "Michelle",
            "middle_initial": "",
            "last_name": "Gallup",
            "subaccount_company_name": "",
            "phone_number": "001-949-5339412-x"
          },
          "contact_address": {
            "address_1": "2144 Michelson Drive",
            "address_2": "",
            "city": "Irvine",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "92612"
          }
        }
      },
      "pma_number": "",
      "k_number": "K231940",
      "products": [
        {
          "product_code": "PNP",
          "created_date": "2024-11-06",
          "owner_operator_number": "10043585",
          "exempt": "",
          "openfda": {
            "device_name": "Dental Abutment Design Software For Dental Laboratory",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.3630",
            "device_class": "2"
          }
        },
        {
          "product_code": "NHA",
          "created_date": "2024-11-06",
          "owner_operator_number": "10043585",
          "exempt": "",
          "openfda": {
            "device_name": "Abutment, Implant, Dental, Endosseous",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.3630",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}