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ENDOCEM MTA PREMIXED REGULAR

MARUCHI · Model ENDOCEM MTA PREMIXED REGULAR · UDI-DI 08800071200291

KIF Prescription

510(k) clearances

703

Adverse events

Recalls

Facilities

Description

ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. It is designed to prevent irritation of pulp and secondary infections. ENDOCEM MTA PREMIXED REGULAR is a tricalcium-silicate based endodontic material as a premixed and preloaded syringe type. It conducts hydration reaction by absorbing the moisture around the root canal. The main compositions, directly relating to hydration reaction forming the hydrate gel, are calcium silicate and calcium aluminate. Bentonite Clay is added for hydrophilic properties inside the root canal so that it helps effective hydration reaction in the environment where there is a small amount of moisture. Other composition is relating to making ENDOCEM MTA PREMIXED REGULAR a premixed syringe type product for convenience usage.

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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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.