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EdgeSeal Root Canal Sealer
EDGE ENDO LLC · Model EESEAL · UDI-DI 00818365020010
KIF
Prescription
10
510(k) clearances
704
Adverse events
2
Recalls
76
Facilities
Description
EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).
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.