(21 days)
Rhodia Putty Dental Impression Materials are intended for use for first impression in the technique of double impression.
Rhodia Putty is used for first impression in the technique of the double impression. It can be used with perforated and non-perforated trays constructed of metal or plastic. The device is a two-part vinyl polysiloxane putty with an addition-cure reaction. The base and catalyst components are mixed together prior to creating an impression.
The provided text describes a 510(k) premarket notification for a dental impression material, Rhodia Dental Putty Impression Material. However, it does not contain the specific details required to answer your questions regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document states that the device "has been tested according to the criteria established in the Guidance Document, 'Dental Impression Materials-Premarket Notification'". This implies that there are established performance standards and testing methodologies for dental impression materials that the device has met. However, the document does not elaborate on what those criteria are, what the reported performance was, or any of the specific details about the study.
Therefore, I cannot provide the requested table, sample sizes, expert details, or ground truth information from this document. The information focuses on regulatory approval and substantial equivalence to pre-amendment devices, rather than a detailed performance study report.
§ 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).