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Use Plastalgin for all routine impressions (e.g., denture dentition construction, orthodontics, study models, or other such routine impressions).

Use Plastalgin Ortho when a faster setting time is needed (e.g., procedure with children, patients with nauseous reflex during impression procedures).

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for two dental impression materials, Plastalgin and Plastalgin Ortho. This document does not contain any information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, or MRMC studies.

The letter primarily:

• Confirms the device is substantially equivalent to a legally marketed predicate device.
• States the regulation number, name, and product code.
• Outlines general control provisions of the Act that the manufacturer must comply with.
• Provides contact information for further guidance.
• Includes an "Indications for Use" statement for the devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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