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TEMREX MATRIX RETAINER

TEMREX CORPORATION · Model 97, 98, 99, 100, 101 · UDI-DI 00850015110627

DZN
10
510(k) clearances
663
Adverse events
2
Recalls
384
Facilities

Description

A dental device designed to engage the ends of a matrix band or strip to hold it in position around a tooth that is being prepared for a dental restoration.

Recalls

DateFirmReason
2015-12-22Ultradent Products, Inc.Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through
2011-12-12Ormco/SybronendoThe Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization

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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.