(61 days)
Fabrication of dental prostheses like: Clasps, provisional bridges, space maintainers, partials orthodontic devices and abutments.
Not Found
This looks like a 510(k) clearance letter for a dental device, "Dental D," not a study report with performance metrics.
Therefore, the provided text does not contain the information requested regarding:
- Acceptance criteria and reported device performance.
- Sample size for test set, data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set.
- Ground truth establishment for the training set.
The document is a regulatory letter from the FDA stating that the device is "substantially equivalent" to previously marketed devices for the fabrication of dental prostheses. It outlines the regulatory classification and general controls applicable to the device. There is no mention of a performance study or specific acceptance criteria within this document.
§ 872.3285 Preformed clasp.
(a)
Identification. A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.