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K Number
K021503
Device Name
UNINHIBITED
Manufacturer
BISCO, INC.
Date Cleared
2002-08-01

(84 days)

Product Code
EBD
Regulation Number
872.3310
Type
Traditional
Panel
DE
Reference & Predicate Devices
K882915
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TO SEAL THE SURFACE OF:

DIRECT COMPOSITE RESTORATIONS INDIRECT COMPOSITE RESTORATIONS AMALGAM RESTORATIONS INTRACORONAL SPLILNTS EXTRACORONAL SPLINTS LINGUAL RETAINERS ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS PROVISIONAL RESTORATIONS PROCESSED ACRYLIC PROSTHESES-REMOVABLE PARTIAL & COMPLETE DENTURES AND MAXILLOFACIAL PROSTHESES PROCESSED ACRYLIC APPLIANCES-ORTHODONTIC RETAINERS

Device Description

UNINHIBITED contains Hexafunctional Urethane Acrylate (30.6%), Polyethylene Glycol (400) Diacrylate (61.4%), phosphine oxide, diphenyl (Photoinitiator) 8.0% 4-methyl methacrylate (Inhibitor) 500 ppm. It is supplied in a bottle. It is applied with a brush to seal the surface of a composite restoration.

AI/ML Overview

The provided text does not contain information on acceptance criteria, device performance, sample size, ground truth establishment, or details about a study to prove the device meets acceptance criteria. The document is a 510(k) premarket notification for a dental sealant called "UNINHIBITED," establishing its substantial equivalence to a predicate device ("Fortify"). It details the device description, intended use, and a comparison table with the predicate device, but no performance studies or specific acceptance criteria are mentioned beyond biocompatibility.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and data provenance
  3. Number of experts used to establish ground truth and their qualifications
  4. Adjudication method
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.