LogoFDA 510(k) Search
K Number
K973541
Device Name
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
Manufacturer
MEDENTAL INTL.
Date Cleared
1997-11-25

(68 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

This is a chemically activated sealant that is used to seal the pit and fissures found in young teeth. This sealant assures complete cure in deep fissures.

Device Description

Chemically Activated Pit and Fissure Sealant

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental sealant. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these aspects of the device's evaluation.

§ 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.