(67 days)
Dental casting alloy for making dental restorations and appliances.
FOR USE WITH DENTAL PORCELAIN NOT (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division ! 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use ------
High gold casting alloy
This report is a 510(k) summary for a dental casting alloy, not a study evaluating an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.
However, I can extract information related to the comparison of the new device to a legally marketed predicate device, which can be seen as an analog to "acceptance criteria" for demonstrating substantial equivalence based on physical and chemical properties.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" for a new device like "Aurecast Bio 69PF" are demonstrating substantial equivalence to a legally marketed predicate device ("Jelenko Benchmark IV"). This is achieved by showing comparable composition and physical/mechanical properties. The tables below outline these comparisons.
| Criterion (Predicate Device: Jelenko Benchmark IV) | Reported Device Performance (Aurecast Bio 69PF) |
|---|---|
| Composition (weight%) | |
| Au: 70 | Au: 69.7 |
| Ag: 12 | Ag: 14 |
| Pt: 5 | Pt: 3.8 |
| Cu: 12.5 | Cu: 10.8 |
| Zn: 0 | Zn: 1.4 |
| In: |
§ 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.