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MTA-Flow Fast Set

Zendo Direct AG · Model ZEN-MTA-FLOFST · UDI-DI 17540208000421

KIF Prescription
10
510(k) clearances
703
Adverse events
2
Recalls
76
Facilities

Description

Endodontic repair cement - 0.25 g capsules

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.