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K Number
K093059
Device Name
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
Manufacturer
CLASSONE ORTHODONTICS, INC.
Date Cleared
2010-02-04

(127 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

SeLECT Defense Dental Pit and Fissure Sealant is a BisGMA based light cured resin for the sealing of deciduous teeth and the filling of fissures in primary tooth structure.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental pit and fissure sealant. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document primarily focuses on:

  • The FDA's determination of substantial equivalence for a physical dental device (SeLECT Defense Dental Pit and Fissure Sealant) to predicate devices.
  • Regulatory information, including product codes, regulation numbers, and compliance requirements.
  • Indications for Use for the dental sealant.

Therefore, I cannot extract any of the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device from this 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.