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K Number
K102252
Device Name
DMP PIT & FISSURE SEALANT
Manufacturer
DMP LTD
Date Cleared
2010-12-03

(115 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
  • Pits and fissures of molars and premolars
  • Fissures on the lingual sides of anterior teeth
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for a dental pit and fissure sealant, which confirms that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements but does not include details on performance studies, acceptance criteria, or ground truth establishment.

§ 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.