Class II — Cosmedent, Inc.
| Recalling firm | COSMEDENT, INC. |
|---|---|
| Registered facility | COSMEDENT, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Reports were received the elastomer cup material is crumbling. |
| Product | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx. |
| Quantity | 7,400 packs of 6 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, UAE, and United Kingdom. |
| Initiated | 2023-07-20 |
| Classified | 2023-11-02 |
| Recall number | Z-0211-2024 |
| 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 — Cosmedent, Inc. (Z-0211-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92812/
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