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GEM 21S®

LYNCH BIOLOGICS, LLC · Model LBGEM05 · UDI-DI 00850001118002

NPZNQA Prescription
0
510(k) clearances
235
Adverse events
1
Recalls
6
Facilities

Description

Growth-Factor Enhanced Matrix for Periodontal Regeneration

Recalls

DateFirmReason
2005-02-17Dentsply Friadent CeramedPepGen P-15 Putty kit was labeled with the incorrect expiration date.

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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.