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K Number
K991909
Device Name
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
Manufacturer
DENTSPLY INTL.
Date Cleared
1999-08-20

(74 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
DE
Reference & Predicate Devices
K942031,K951296,K982564
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

preventive sealing of pits and fissures in the primary and secondary dentition in combination with the acid-etch technique.

Device Description

DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT is a visible light-cured, radiopaque, resinous material designed for application to the occlusal surfaces of caries-susceptible posterior teeth to seal irregularities and prevent ingress of oral fluids, food and debris. DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT also includes DELTON® Etchant Gel, a DENTSPLY legally marketed device (K942031). The sealant is dispensed to the acid-etched tooth via an individually filled cartridge inserted into the applicator handle (Direct Delivery System).

AI/ML Overview

This looks like a 510(k) premarket notification for a dental sealant, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics (like MRMC studies, training/test set sizes, expert ground truth, etc.) is not applicable here because:

  • No AI/ML Component: The device, DELTON® FS WITH FLUORIDE PIT & FISSURE SEALANT, is a physical material used for sealing teeth. It does not involve any artificial intelligence or machine learning components.
  • Predicate Device Comparison: The submission primarily relies on demonstrating substantial equivalence to previously marketed predicate devices (DELTON® Plus Pit & Fissure Sealant and DELTON® FS Direct Delivery System) based on similar composition, intended use, and physical properties.
  • Performance Data Type: The "performance data" mentioned in the document refers to physical property comparisons of the sealant material, not diagnostic or predictive performance metrics typically associated with AI.

Therefore, I cannot provide the requested table and study details as they pertain to AI/ML device evaluations. The provided document details a different type of medical device submission.

§ 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.