Home › Meta Biomed Co., Ltd. › GuttaSil
GuttaSil
Meta Biomed Co., Ltd. · Model 9387 · UDI-DI 08806387893875
1
510(k) clearances
129
Adverse events
3
Recalls
110
Facilities
Description
GuttaSil, a product in the form of a paste which combines gutta-percha with a sealer. The gutta-percha powder is mixed in a matrix of polyvinylsiloxane. It is convenient since sealing and obturation are simultaneously possible without heating and the root canal can be filled in a quick manner. This device contains a syringe, auto-mix& Endo tips, spatula, and mixing pads.
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 |
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 docsData 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.