(51 days)
Bio PontoStar is a metal to ceramic type 4 alloy. I is a medical device in accordance with Regulation 93/42 EEC. Class Iia according to Annex IX.
Bio PontoStar is a metal to ceramic type 4 alloy.
This document is a marketing authorization letter from the FDA for a dental alloy device (Bio PontoStar). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, I cannot answer your request based on the provided text. The document confirms that the device is "substantially equivalent" to previously marketed devices, allowing it to be sold, but it does not detail the technical performance evaluations.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.