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Biotem

Biotem Co., ltd · Model FP21H · UDI-DI 08800036206641

EBL
10
510(k) clearances
3
Adverse events
1
Recalls
52
Facilities

Description

Biotem FIXTURE PIN

Recalls

DateFirmReason
2021-03-18Coltene Whaledent IncThe incorrect dental pins were packaged and subsequently distributed.

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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.