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OpalCups Finishing
ULTRADENT PRODUCTS, INC. · Model 5799 · UDI-DI 00883205019905
EHK
Prescription
8
510(k) clearances
3
Adverse events
1
Recalls
121
Facilities
Description
OpalCups Finishing 20 pack
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-20 | Cosmedent, Inc. | Reports were received the elastomer cup material is crumbling. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.