Rubber Dam Clamp — Class II medical device recall Z-1676-2021
Terminated recall by Dentech Corp., reported 2021-06-02, distributed nationwide. Removing parts for safety reasons due to possible breakage.
| Recall number | Z-1676-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dentech Corp., Tokyo, N/A, Japan |
| Recall initiated | 2021-04-21 |
| Classified | 2021-05-25 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2023-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BG, CA, CN, EG, FR, GB, GR, GT, ID, IL, IN, IQ, KR, LT, MY, NO, PL, RO, RU, SE, SG, SI, TW, UA |
| Quantity | 87,842 units |
| Reason classes | device malfunction |
| Lot numbers | 1805F039, 1805F055, 1805H023, 1806F049, 1806F058, 1806G005, 1806G010, 1806G011, 1806I002, 1806I006, 1807A026, 1808A006, 1808A011, 1809A013, 1809B011, 1809B013, 1809F005, 1810G008, 1810J009, 1810J011, 1810K008, 1810K009, 1810K012, 1810K013, 1811C001, 1811C007, 1811J010, 1812F019, 1812F024, 1812F027, 1812G003, 1812G005, 1812L014, 1812L015, 1901G007, 1901G043, 1902C003, 1902F001, 1902F003, 1903A003 and 304 more |
Product
Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
Reason for recall
Removing parts for safety reasons due to possible breakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1676-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.