REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.

• K Number: K963747
• Device Name: REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.
• Manufacturer: WHITEHILL MANUFACTURING, INC.
• Date Cleared: 1996-12-16 ( 90 days)
• Product Code: JET
• Regulation Number: 872.6650
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K070127

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 872.6650 Massaging pick or tip for oral hygiene.

(a)
Identification. A massaging pick or tip for oral hygiene is a rigid, pointed device intended to be used manually to stimulate and massage the gums to promote good periodontal (gum) condition.(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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.