DECAPINOL ORAL RINSE

• K Number: DEN050001
• Device Name: DECAPINOL ORAL RINSE
• Manufacturer: SINCLAIR PHARMACEUTICALS LIMITED
• Date Cleared: 2005-04-18 ( 84 days)
• Product Code: NTO
• Regulation Number: 872.5580

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

§ 872.5580 Oral rinse to reduce the adhesion of dental plaque.

(a)
Identification. The device is assigned the generic name oral rinse to reduce the adhesion of dental plaque and is identified as a device intended to reduce the presence of bacterial plaque on teeth and oral mucosal surfaces by physical means. The device type includes those devices that act by reducing the attachment and inhibiting the growth of bacterial plaque.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.” See § 872.1(e) for the availability of this guidance document.

Summary

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