{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dearborn",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89449",
      "recalling_firm": "Envisiontec US Llc",
      "address_1": "15162 S Commerce Dr",
      "address_2": "N/A",
      "postal_code": "48120-1237",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0643-2022",
      "product_description": "FLEXCERA SMILE  -a Dental resins for the fabrication of artificial teeth",
      "product_quantity": "795 units",
      "reason_for_recall": "Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin",
      "recall_initiation_date": "20220106",
      "center_classification_date": "20220215",
      "report_date": "20220223",
      "code_info": "Manufactured from April 1, 2021 to September 15, 2021.  Lot Numbers: 120421-a 70921  30521    180621d   010421     140621a  060721a    120421-b 270521  130521a    090721a   060421-a     140621b  060721b    120421-c 030621  130521b    090721b   060421-b     140621c  060721c    220421-a 160721a  130521c    130721a   060421-c     150621a  060721d    220421-b 160721b  200521a    130721b   080421-a     150621b  070721a    220421-c 180721  200521b    130721c   080421-b     150621c  070721b    230621a 280721  200521c    130721d   080421-c     210621a  070721c    230621b 290721  250521a    300821a   130421-a     210621b  070721d    230621c 100821  250521b    300821b   130421-b     210621c  080721a    230621d 100821  250521c    310821a   130421-c     210621d  080721b    170721a 090621c  310521a    210721a   200421-a     220621a  080721c    170721b 180721a  310521b    210721b   200421-b     220621b  080721d    190721 180721b  310521c    210721c   200421-c     220621c  120721a    290721a 180721c  070621a    40821   260421-a     220621d  120721b    290721b 180721d  070621b    60821   260421-b     300621a  120721c    290721c 190721a  070621c    130821   260421-c     300621b  120721d    90821 190721b  110621a    090921-2   270421-a     300621c  140721a    110821 160821  110621b    100921   270421-b     300621d  140721b    120821 270821  110621c    140921-1   270421-c     050721a  140721c    190821 190421a  180621a    140921-2   030521     050721b  140721d    230821 190421b  190621b    140921-3   040521a     050721c  150721a    240821 190421c  180621c    140921-4   040521b     050721d  200721a    070421-a 210421-a  260521a    290621a   040521c     310821b  200721b    070421-b 210421-b  260521b    290621b   170521a     010921a  200721c    070421-c 210421-c  160621a    290621c   170521b     010921b  200721d    170821 280721a  160621b    290621d   170521c     020921a  300721a    180821 280721b  160621c    280621a   180521a     020921b  300721b    110521 280721c  160621d    280621b   180521b     030921a  300721c    200821 030821a  170721    280621c   180521c     030921b  50821    020621 030821b  140421-b    280621d   190521a     070921      200421 030821c  140421-a    020821a   090621a     080921      250821 130921-1  180821b    020821b   090621b     080921-2      260821 130921-2  100921-2    020821c   090921     140421-c"
    }
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}