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PRAXIS
TDV DENTAL LTDA · Model 0002000051 · UDI-DI 07897990300769
4
510(k) clearances
6
Adverse events
2
Recalls
92
Facilities
Description
Praxis Refill 1/2" - 50 X-Fine Discs (EN)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-28 | Ultradent Products, Inc. | Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. |
| 2016-07-11 | Ivoclar Vivadent, Inc. | After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to Op |
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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.