Search Results
Found 3 results
510(k) Data Aggregation
(44 days)
Zhermack HYDROGUM 5 is a dental impression material intended to be placed on a preformed tray and used to reproduce the structure of a patients teeth, inlays and dentures. It is also intended to provide models of outletted in as dental inlays and dentures.
Not Found
This document is a 510(k) premarket notification from the FDA and does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria.
The document states that the FDA has reviewed the 510(k) submission for the "Hydrogum 5" dental impression material and determined it is substantially equivalent to legally marketed predicate devices. This means the device is considered as safe and effective as other similar devices already on the market, but it does not provide details of specific performance criteria or a study proving it meets them.
Therefore, I cannot provide the requested information based on the provided text.
Ask a specific question about this device
(75 days)
Ask a specific question about this device
(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.
Ask a specific question about this device
Page 1 of 1