(58 days)
Tulip Alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
Tulip Alginate impression material is a dental impression material based on alginate.
The provided text is a 510(k) clearance letter from the FDA for a dental impression material named "Tulip Alginate Impression Material." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be typically associated with an AI/ML device or a complex diagnostic medical device.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the clearance was based on demonstrating substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be required for novel or high-risk devices.
Therefore, I cannot provide the requested information from the given text. The text does not describe a study proving the device meets acceptance criteria in the manner you've outlined.
§ 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).