FDA Device Intelligence
HomeMeta Biomed Co., Ltd. › Gutta Percha 02-LM-45/80

Gutta Percha 02-LM-45/80

Meta Biomed Co., Ltd. · Model 0725 · UDI-DI 08806387807254

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

Description

Gutta Percha Points and Bars, Length Marked 02 taper 45/80, 120 Points, P 31S

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.