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K Number
K011822
Device Name
PIT AND FISSURE CHEMICAL CURING SEALANT
Manufacturer
RITE-DENT MANUFACTURING CORP.
Date Cleared
2001-08-07

(57 days)

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

This is a chemically activated sealant that is used to seal the pit ad fissures found in primary and secondary dentition in combination with the acid etching technique. This sealant assures complete cure in deep fissures.

Device Description

Pit and Fissure Sealant

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental pit and fissure sealant. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study. This document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.

§ 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.