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Gentle Hand-Bur Systems

DENTAL CARE FOR ALL INTERNATIONAL · Model C4 · UDI-DI 00860007700842

DZN

510(k) clearances

663

Adverse events

Recalls

384

Facilities

Description

C4: Our clamp-lock system (ideally) uses a tray-set of 4 handles with bur sizes #2,4,6,8. These pen-style, pin vise (PSPV) aluminum handles securely anchor 2 mm in diameter HP 44.5 mm dental burs. Perforated "Pin-Lock" handles twist-tighten (with a locking-pin) a micro-chuck assembly (MCA) bur-anchoring mechanism. The MCA is coupled with a smooth grip clamp-lock tightening device which grips the MCA's outer collar (compression sleeve) for counter pressure tightening with the locking pin. Testing has proven that supplemental mechanical force makes it impossible for a bur to loosen while in use.

Recalls

Date	Firm	Reason
2015-12-22	Ultradent 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
2011-12-12	Ormco/Sybronendo	The 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.