TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND

• K Number: K000996
• Device Name: TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
• Manufacturer: DENTSPLY INTL.
• Date Cleared: 2000-06-16 ( 80 days)
• Product Code: EFT
• Regulation Number: 872.3520

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

§ 872.3520 OTC denture cleanser.

(a)
Identification. An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.(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.

Summary

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