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K Number
K061581
Device Name
EXCEL HIGH SPEED DENTAL HANDPIECE
Manufacturer
ORTHOSOURCE, INC.
Date Cleared
2006-08-16

(70 days)

Product Code
EFA
Regulation Number
872.4200
Type
Abbreviated
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The dental high speed handpiece is a precision instrument used by a dental professional for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, and for cosmetic corrections. Note Federal Law restricts the use of this device to dental professionals.

Device Description

Excel High Speed Hand Piece

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental handpiece, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, intended use, and general controls, but does not include details on specific performance acceptance criteria or performance study results.

§ 872.4200 Dental handpiece and accessories.

(a)
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.(b)
Classification. Class I.