(44 days)
Hydrogum is an alginate dental impression material that is intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth.
Hydrogum is an alginate dental impression material.
I'm sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter for a dental impression material (Hydrogum) and an "Indications for Use Statement." These documents do not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth methodologies as would be found in a clinical study report or a more detailed regulatory submission.
The letter primarily focuses on:
- Confirming the substantial equivalence of Hydrogum to a legally marketed predicate device.
- Outlining regulatory requirements for the manufacturer.
- Stating the intended use of the device.
Therefore, the specific quantitative details you're asking for regarding device performance and study methodology are not present in this 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).