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PERK Emergency Denture Repair Kit

PERMA LABORATORIES LLC · Model pk6 · UDI-DI 00852305002117

EBO
7
510(k) clearances
6
Adverse events
0
Recalls
8
Facilities

Description

A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.

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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.