FDA Device recall Z-0643-2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
- FDA Device
- Class II
- ongoing
- Published 2022-02-23
On 2022-02-23 the FDA classified a Class II recall of FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth by Envisiontec Us, citing manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0643-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-06 |
| Published | 2022-02-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Envisiontec Us |
| Distribution | US |
Product
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Reason
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
Identifiers
| code_info | Manufactured from April 1, 2021 to September 15, 2021. Lot Numbers: 120421-a 70921 30521 180621d 010421 1406…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0643-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.