(12 days)
Zhermack ZETAPLUS SOFT a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. ZETAPLUS SOFT is material for preliminary impression (first impression).
Not Found
This FDA 510(k) clearance letter for the Zetaplus Soft dental impression material does not contain the detailed information requested regarding acceptance criteria and study data.
The document is a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices. It provides:
- Trade/Device Name: Zetaplus Soft
- Regulation Number and Name: 872.3660, Impression Material
- Regulation Class: II
- Product Code: ELW
- Indications for Use: "Zhermack ZETAPLUS SOFT a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. ZETAPLUS SOFT is material for preliminary impression (first impression)."
However, it does not include any studies, performance data, or acceptance criteria in the format requested. These details would typically be found in the 510(k) submission itself, which is a much larger technical document not included in this clearance letter.
Therefore, I cannot populate the table or answer the specific questions about the study from 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).