(79 days)
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).
Not Found
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.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).