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MTA-FILLAPEX
Angelus Industria de Produtos Odontologicos S A · Model MTA-Fillapex 4g · UDI-DI 07898078658277
KIF
Prescription
10
510(k) clearances
704
Adverse events
2
Recalls
76
Facilities
Description
Bioceramic Root Canal Sealer - MTA-Fillapex 4g MTA-Fillapex is a bioceramic root canal sealer based on MTA (mineral trioxide aggregate). Its composition provides long term sealing capacity, high radiopacity, promotes the stimulation of hard tissue formation in the dental apex and perforation sites, low expansion during setting, low solubility in contact with tissue fluids, excellent viscosity for insertion, does not stain the tooth, it is a eugenol-free material and has appropriate working time for endodontic procedures.
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.