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FIBRAPOST PLUS N°1-4 (24 glass fibre posts + 4 reamers + 1 screwdiver)

Produits dentaires S.A. · Model 22595 · UDI-DI 07640159162889

ELR Prescription
10
510(k) clearances
131
Adverse events
2
Recalls
97
Facilities

Description

Core build up - 6 posts + 1 reamer RA of each #1-4 - N°1 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 0.85mm Diameter of the cylindrical part 1.30mm N°2 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 1.06mm Diameter of the cylindrical part 1.50mm N°3 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 1.26mm Diameter of the cylindrical part 1.70mm N°4 Total Length 19mm Length of tapered part 11mm Diameter of the lower tip 1.47mm Diameter of the cylindrical part 1.90mm

Recalls

DateFirmReason
2018-08-21Coltene Whaledent IncParaPost Plus Titanium Posts contain stainless steel post that are a size 4
2009-03-20Dentsply Worldwide HeadqrtThe product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the thread

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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.