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Dentaurum GlasTec Dental Orthodontic Cement is a dental glass ionomer cement used to cement orthodontic bands to tooth surfaces.

Dentaurum GlasTec Dental Orthodontic Cement

Considering the provided text, which is an FDA 510(k) clearance letter for a dental orthodontic cement, it's important to understand that this type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, and data provenance for a medical device's performance evaluation.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting detailed clinical study results or performance against specific acceptance criteria in the format you've outlined. The letter confirms that the device is substantially equivalent for its stated indications for use.

Therefore, I cannot extract the requested information from the provided text. The document is an administrative clearance, not a technical report or study summary.

To answer your prompt, I would expect to see a safety and effectiveness summary, clinical study report, or similar technical documentation that describes the device's performance characteristics and how they were evaluated.

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