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K Number
K040599
Device Name
PARKELL RESIN GLAZE
Manufacturer
PARKELL, INC.
Date Cleared
2004-04-09

(32 days)

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

A nanofilled, light-cured, clear resin intended for use by a indications I or Goor Amanonization of a glaze and sealant for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces without oxygen-inhibition and impart high only and restoration durability and resistance to abrasive wear. This is exportune is substantially equivalent to other FDA-certified devices (cited above) marketed in the USA. It functions in a manner similar to them and is intended for the same use as these predicate devices.

Device Description

A nano-filled, light-cured, clear resin intended for use by a duly licensed professional as a glaze and sealer for composite resin restorations or for acrylic, bis-acryl and/or composite temporary materials. It can be used to impart high sheen and seal to appropriate surfaces. Cures without oxygen-inhibition and is expected to extend restoration durability and resistance to abrasive wear. This material is substantially equivalent to other FDA-certified devices (cited above) marketed in the USA. It functions in a manner similar to them and is intended for the same use as these predicate devices.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Resin Glaze) and correspondence from the FDA. It does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on general administrative and classification details, including:

  • Submitter and contact information
  • Submission date
  • Trade and common name of the device
  • Classification information
  • Equivalence to predicate devices
  • Description and Intended Use
  • FDA's letter of substantial equivalence approval

Therefore, I cannot provide the requested information about acceptance criteria and a study to prove device performance based on the given text.

§ 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.