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Cold-curing, methyl methacrylate resin for adding the saddles to cobalt chrome denture bases, repairs, additions and relines, and relines. Cold-curing, methyl methacrylate resin for the completion of full and partial dentures. Cold-curing, methyl methacrylate resin for adding saddles to cobalt chrome dentures bases, repairs, additions and other repairs. Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e. g. Unipress). Cold-curing repair resin for additions, replacing teeth and relining dentures. Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection moulding systems. Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and other repairs.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for several dental resins. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

The document does not contain any information about:

• Acceptance criteria table or reported device performance for a study.
• Sample sizes used for test sets or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm only) performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

Therefore, I cannot fulfill your request for this information based on the provided text.

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