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K Number
K012542
Device Name
REVOTEK LC
Manufacturer
GC AMERICA, INC.
Date Cleared
2001-10-16

(70 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

GC Revotek LC is a paste type light cured resin used to fabricate temporary crowns, bridges as well as following to temporary crowns, bridges: as used to fabricate temporary crowns, bridges as well as inlays, onlays, and veneers.

Device Description

GC Revotek LC is a paste type light cured resin

AI/ML Overview

The provided text is a letter from the FDA regarding the clearance of a medical device, Revotek LC. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot provide the requested information based on the given input.

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.