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PD MTA White

Produits dentaires S.A. · Model 20190 · UDI-DI 07640159160014

KIF Prescription
10
510(k) clearances
704
Adverse events
2
Recalls
76
Facilities

Description

PD MTA White is a radiopaque root canal repair material material. The material composed of several mineral oxides is made up of thin hydrophilic particles showing the following advantages : – Optimized particle size allowing homogeneous and complete wetting during mixing – Avoids bacterial migration and penetration of tissue fluids into the root canal thanks to its excellent marginal sealing capacity – No need to dry the treated site. PD MTA White properties are not decreased in a moist environment The powder mixed with distilled water forms a gel, which cures in a humid environment. The material starts setting after approximately 10 minutes and the final setting time is 15 minutes. It is not necessary to wait for the final setting to continue the treatment procedure. Indications – Treatment of perforations of root canal and furcation – Treatment of internal resorption – Retrograde root canal filling after apical resection – Pulp capping – Pulpotomy – Apical plug during apexification treatment

Recalls

DateFirmReason
2016-08-31Ormco/SybronendoSybronEndo 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
2009-02-23Sybron Dental SpecialtiesSybron 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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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.