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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.

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.

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.

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