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GUTTA PERCHA POINT 6%, Assortment 20-45

Produits dentaires S.A. · Model 24046 · UDI-DI 08809264293263

EKM Prescription

510(k) clearances

128

Adverse events

Recalls

106

Facilities

Description

Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is used to fill the endodontic cavity to result in complete sealing in order to prevent reoccurrence of pathologies in root canal which may occur if root canal is not obturated. Box of 60 pieces - Length 28mm N°20-25-30-35-40-45

Recalls

Date	Firm	Reason
2016-02-08	Ormco/Sybronendo	Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as S
2010-09-09	Ormco Corporation	The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
2009-10-27	Sybronendo	The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability requ

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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.