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Compo-Dots Composite Condensing Dot Large

PRACTICON, INC. · Model .3125DIAx3/16" · UDI-DI 00723896010709

DZN
10
510(k) clearances
656
Adverse events
2
Recalls
382
Facilities

Description

Rid your composite restorations of voids and open margins!Compo-Dots Composite Condensing Dots are tiny, non-stick foam sponges perfectly sized to condense composites into Class I, II and III preps. Elastic memory provides an ideal compressive force and prevents "draw-back" of composite materials upon removal. 100 disposable blue dots per bag. Large Compo-Dots for Class I and large Class II preps.

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.