(51 days)
¾ and single crowns, inlays, veneer crowns and short span bridges.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "NDX-40." It does not contain information about acceptance criteria, study design, or performance data beyond the device's indications for use. Therefore, I cannot generate the requested table and study details.
The document indicates:
- Device Name: NDX-40
- Indications For Use: "¾ and single crowns, inlays, veneer crowns and short span bridges."
- Regulation Number: 21 CFR 872.3060 and 21 CFR 872.5000 (Gold Based Alloys and Precious Metal Alloys for Clinical Use)
- Regulatory Class: II
- Product Code: EJT
To provide the information you requested, I would need a different document, such as the actual 510(k) summary or a clinical study report that details the performance testing of the NDX-40.
§ 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.