(65 days)
APOLLO 3 ALLOY is indicated as a dental alloy for fabricating inlays, crowns and small span bridges.
APOLLO 3 ALLOY is a yellow, high noble, gold-based dental alloy.
The provided document is a 510(k) summary for a dental alloy, APOLLO 3 ALLOY. It does not describe an AI/ML powered device, nor does it present any studies involving human readers, ground truth establishment, or performance metrics typically associated with AI/ML devices. Therefore, I cannot extract the requested information related to AI/ML device acceptance criteria and study details from this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Degulor M Alloy K951779) based on its material composition, historical use, and biocompatibility testing. It states that APOLLO 3 ALLOY was found to be non-cytotoxic and non-mutagenic, and that other components have been used in legally marketed devices.
If you have a document pertaining to an AI/ML powered device, please provide that for analysis.
§ 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.