SIRIUS 10, 10L, 40, 40L

• K Number: K961275
• Device Name: SIRIUS 10, 10L, 40, 40L
• Manufacturer: MICRO-MEGA SOCIETE ANONYME
• Date Cleared: 1997-01-17 ( 289 days)
• Product Code: EFB
• Regulation Number: 872.4200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 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.