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Gutta Percha 06-LM-45

Meta Biomed Co., Ltd. · Model 0519 · UDI-DI 08806387805199

EKM Prescription
10
510(k) clearances
128
Adverse events
3
Recalls
106
Facilities

Description

Gutta Percha Points and Bars Length Marked 06 taper #45, 60Points, P71

Recalls

DateFirmReason
2016-02-08Ormco/SybronendoOrmco 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
2010-09-09Ormco CorporationThe recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.
2009-10-27SybronendoThe 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.