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2PRO

PREMIER DENTAL PRODUCTS COMPANY · Model 5510001 · UDI-DI 00348783004335

EHK Prescription
8
510(k) clearances
3
Adverse events
1
Recalls
123
Facilities

Description

2PRO BULK PK-Soft/Short/Purple-1000

Recalls

DateFirmReason
2023-07-20Cosmedent, Inc.Reports were received the elastomer cup material is crumbling.

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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.