(70 days)
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Cera E alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Cera E Dental Alloy
The provided document is a 510(k) clearance letter from the FDA for a dental alloy device (Cera E Dental Alloy). It states that the device is substantially equivalent to legally marketed predicate devices.
*However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or any other performance metrics typically associated with detailed device performance studies.
The letter is a regulatory approval, not a scientific study report. It focuses on:
- Substantial Equivalence: The primary basis for 510(k) clearance is demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often means similar technological characteristics and indications for use, without raising new questions of safety and effectiveness.
- Intended Use Statement: The "Indications for Use" section (Page 3) describes how the device is intended to be used (e.g., by a dental lab technician for specific types of dental prostheses). This is a critical part of the regulatory submission.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the provided text. The document simply doesn't contain that kind of information.
§ 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.