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Gentle Hand-Bur Systems

DENTAL CARE FOR ALL INTERNATIONAL · Model P2 · UDI-DI 00860007700804

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

Description

P2: A “P2” dental hand-bur handle, is a "premium" locking-handle which consists of a round, threaded, aluminum handle which embodies a heavy-duty micro-chuck assembly (MCA). The MCA embodies a threaded end which screws into the handle’s internal threads in order to secure a dental bur so it cannot dislodge while in use. To secure a dental bur after insertion, a bur-locking-wrench grips the MCA and is counter-tightened by a locking pin at the handle’s opposite end. The MCA’s outer sleeve embodies two locking grooves (or slots) that engage a 7 mm bur-locking “wrench” or “key.” The casing is made of durable, 2 mm 6061-T6 medical grade aluminum designed for maximum strength and longevity. Rightly classed as a “premium” model, it can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. Learn more about our mission at dentalcareforall.org. If you have any complaints with our products please call or email us for immediate resolution: email team@dcfai.org / Call +19562801708 (WhatsApp)

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.