(64 days)
Zhermack COLORBITE is a dental impression material indications Tor 650. of a patient's teeth.
COLORBITE is a dental impression material.
The provided text is a 510(k) premarket notification letter from the FDA regarding a dental impression material called "Colorbite." This document confirms that the device has been found substantially equivalent to predicate devices, allowing it to be marketed. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish acceptance criteria or performance metrics in the same way a PMA (Premarket Approval) might.
Therefore, I cannot provide the requested information based on the input text. The document does not describe:
- A table of acceptance criteria or reported device performance.
- Sample sizes or data provenance for any test set.
- The number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect sizes.
- Standalone performance studies.
- The type or method for establishing ground truth for any set.
- Sample size or ground truth establishment for a training set.
§ 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).