(14 days)
Dental casting Type III alloys intended for manufacturing: Crowns Short Span Bridges Inlays
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental alloy device (Starcast Dental Alloys). It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
Therefore, I cannot provide the requested information from this document. The document primarily focuses on:
- Device Name: Starcast Dental Alloys
- Regulation Number: 21 CFR 872.3060
- Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use
- Regulatory Class: II
- Product Code: EJT
- Indications for Use: Dental casting Type III alloys intended for manufacturing: Crowns, Short Span Bridges, Inlays
- FDA Determination: Substantially equivalent to legally marketed predicate devices.
- General Controls: Requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
To answer your questions, I would need a technical study report, a submission summary, or a similar document describing the actual performance testing of the device.
§ 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.