LARES 757 WORKHORSE HIGHSPEED HANDPIECE

K905541 · Lares Research, Inc. · EFB · Mar 7, 1991 · Dental

Device Facts

Record IDK905541
Device NameLARES 757 WORKHORSE HIGHSPEED HANDPIECE
ApplicantLares Research, Inc.
Product CodeEFB · Dental
Decision DateMar 7, 1991
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.4200
Device ClassClass 1

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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