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K Number
K042200
Device Name
MI PASTE
Manufacturer
GC AMERICA, INC.
Date Cleared
2004-10-20

(68 days)

Product Code
EJR
Regulation Number
872.6030
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This product is to be used for cleaning and polishing as a professionally administered prophylaxis treatment. Secondarily, MI Paste can be used for the management of tooth sensitivity, postscaling, root planing and bleaching.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) clearance letter for a dental product called "MI Paste," classifying it and stating its indications for use. It doesn't include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for a device performance study.

§ 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.