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K Number
K031811
Device Name
PIT & FISSURE SEALANT WITH FLUORIDE
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
2003-09-04

(84 days)

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

Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.

The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades, when differen! shades are indicated for use.

Device Description

Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades.

AI/ML Overview

This is a 510(k) clearance letter from the FDA for a dental sealant. This document does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

§ 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.