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Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange

DEN-MAT HOLDINGS, LLC · Model 209007 · UDI-DI 00359883000882

DZN Prescription
10
510(k) clearances
663
Adverse events
2
Recalls
383
Facilities

Description

Device to engage the matrices and separate teeth

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.