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OptraGloss

IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Model 706172WW · UDI-DI 07615208458077

EHJ Prescription
4
510(k) clearances
6
Adverse events
2
Recalls
92
Facilities

Description

OptraGloss Test Pack 2

Recalls

DateFirmReason
2026-01-28Ultradent Products, Inc.Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
2016-07-11Ivoclar 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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Data 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.