(49 days)
For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges and Implant-supported Prosthesis Substructures.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental alloy, Deltapal. It confirms the device's substantial equivalence to a legally marketed predicate device.
The document does not contain information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
This document is a regulatory approval letter for a physical material (dental alloy), not a software or AI-driven diagnostic device. Therefore, the types of detailed performance studies and criteria you're asking for are not typically included in such an FDA clearance letter for this kind of product.
§ 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.