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Stabilok

FAIRFAX MEDICAL PRODUCTS LIMITED · Model Standard yellow · UDI-DI 05060489370044

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

Description

Intended use to anchor a dentine pin in tooth dentine prior to building up the tooth. 20 single use pins + 1 reusable drill

Recalls

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

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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.