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510(k) Data Aggregation
(230 days)
ResiGlass Paste is intended for cementation of permanent restorations including crowns and bridges etc. to natural teeth and other materials.
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I am sorry, but the provided text from the FDA 510(k) letter for "RESIGLASS PASTE" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory information such as:
- Trade/Device Name: RESIGLASS PASTE
- Regulation Number and Name: 21 CFR 872.3275, Dental Cement
- Regulatory Class: II
- Product Code: EMA
- Indications For Use: Cementation of permanent restorations including crowns and bridges etc. to natural teeth and other materials.
- Approval Date: March 28, 2012
This type of document does not typically include detailed performance study results or acceptance criteria, which would usually be found in the 510(k) submission itself or in a summary of safety and effectiveness.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.
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