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K Number
K981990
Device Name
MRS-400, MAXI 400, MRSL-400, MAXI 400L
Manufacturer
D.B.I. AMERICA CORP.
Date Cleared
1998-06-22

(14 days)

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

The dental handpiece is intended to be used by dentists to prepare dental cavities for restorations such as fillings and for cleaning teeth.

Device Description

Dental Handpiece and Accessories (21 CFR 872.4200)

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental handpiece and accessories, dated June 22, 1998. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document.

§ 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.