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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.

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