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Opalpix

ULTRADENT PRODUCTS, INC. · Model 6600 · UDI-DI 00883205015273

JET Prescription
10
510(k) clearances
102
Adverse events
2
Recalls
126
Facilities

Description

Opalpix 32ct 12pk

Recalls

DateFirmReason
2022-12-05Young Dental Manufacturing I, LLCmislabeled product
2018-07-02Water Pik, Inc.Charging base may overheat with localized melting and sparking, possibly causing fire, shock or burns.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.