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K Number
K061997
Device Name
PREMIER SELF-ETCHING ENAMEL SEALANT
Manufacturer
PREMIER DENTAL PRODUCTS CO.
Date Cleared
2006-10-04

(82 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

Premier Self-Etching Enamel Sealant is for the preventive sealing of pits and fissures in the primary and secondary dentition, utilizing the self-etching technique. Secondarily, the material can be used as a sealant/lining under amalgam restorations.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a dental sealant and does not include details about device performance studies, sample sizes, ground truth establishment, or expert qualifications.

§ 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.