POWERED TOOTHBRUSH

• K Number: K970381
• Device Name: POWERED TOOTHBRUSH
• Manufacturer: EMJOI ACTION USA, LTD.
• Date Cleared: 1997-04-18 ( 74 days)
• Product Code: JEQ
• Regulation Number: 872.6865
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 872.6865 Powered toothbrush.

(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.