PROCLUDE

• K Number: K002989
• Device Name: PROCLUDE
• Manufacturer: ORTEK THERAPEUTICS, INC.
• Date Cleared: 2000-12-14 ( 80 days)
• Product Code: EJR
• Regulation Number: 872.6030

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

§ 872.6030 Oral cavity abrasive polishing agent.

(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(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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