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K Number
K120037
Device Name
BLUWHITE DIAMOND DENTAL BURS MODIFIED
Manufacturer
BEAVERS DENTAL, DIV. SYBRON CANADA, LTD.
Date Cleared
2012-04-20

(106 days)

Product Code
DZP
Regulation Number
872.4535
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 872.4535 Dental diamond instrument.

(a)
Identification. A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.