Class II — Dentech Corp.
| Recalling firm | DENTECH CORP. |
|---|---|
| Registered facility | DENTECH CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Removing parts for safety reasons due to possible breakage. |
| Product | Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment. |
| Quantity | 87,842 UNITS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of CA, MN, KY, WA and the countries of Russia, Libya, Moldova, China, Egypt, India, Canada, Guatemala, Iraq, Saudi Araba, Australia, Ukraine, Israel, Indonesia, Malaysia, UK, Singapore, South Korea, Georgia, Taiwan Lithuania, Greece, Sweden, Netherland, France, Poland, Slovenia, Bulgaria, Norway and Romania. |
| Initiated | 2021-04-21 |
| Classified | 2021-05-25 |
| Terminated | 2023-01-12 |
| Recall number | Z-1676-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Dentech Corp. (Z-1676-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87847/
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