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Bite Dx Occlusal Pain Diagnostic Instruments

PRACTICON, INC. · Model 7136615 · UDI-DI 00723896008836

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

Description

While competitive products work well to identify fractures and to isolate pain associated with a single cusp, their small size and hard plastic construction slip around and are inadequate for diagnosing chewing pain unrelated to cracked teeth. The Bite Dx Occlusal Pain Diagnostic Instrument allows the patient to bite down onto soft, non-slip elastomer pads with all cusps of a single tooth at one time to detect chewing pain on all types of teeth. Helps diagnose PDL inflammation and the spread of pulpitis to the apical ligament, in addition to cracks. Tough polypropylene handle also features a traditional pyramid-shaped end for cusp fracture detection. Fully autoclavable

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.