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K Number
K993716
Device Name
PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
Manufacturer
HARRY J. BOSWORTH CO.
Date Cleared
1999-12-21

(49 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PA GEL 35% AND PA GEL 10% are indicated for use when etching of tooth dentin or enamel is required before bonding to the tooth structure. Ten percent concentration is indicated for either tooth dentin or enamel etching. Thirty-five percent concentration is indicated only for tooth enamel etching.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them according to your requested format.

The document is a 510(k) clearance letter from the FDA for a dental etching gel (PA Gels 35% and 10%). While it states that the device is "substantially equivalent" to predicate devices, it does not provide:

  • A table of acceptance criteria and reported device performance.
  • Details of any specific study (sample sizes, data provenance, ground truth establishment, adjudication methods, number/qualifications of experts) for proving the device meets acceptance criteria. This type of detail is typically found in the 510(k) submission itself, not in the clearance letter.
  • Information about MRMC comparative effectiveness studies or standalone algorithm performance, as this document is for a physical dental product, not an AI/software device.
  • Sample sizes for training sets or how ground truth was established for them.

The letter focuses on regulatory clearance based on substantial equivalence, general controls, and good manufacturing practices, rather than detailed performance study results.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.