BLUWHITE DIAMOND DENTAL BURS MODIFIED

• 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

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 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.

Summary

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