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Komet BioSeal Starter Kit 2.2 g
NUSMILE, LTD. · Model KBCS1 · UDI-DI 00850008515231
10
510(k) clearances
704
Adverse events
2
Recalls
76
Facilities
Description
For use in obturating root canals as part of orthograde root canal therapy with gutta percha.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-08-31 | Ormco/Sybronendo | SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 20 |
| 2009-02-23 | Sybron Dental Specialties | Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by pre |
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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.