Search Results

This product is intended for use in fabricating oral crowns, bridges, laminate veneers, inlays and onlays for dental use.

The GC Initial dental ceramic system is a feldspathic porcelain system based on partially crystalline but mostly vitreous materials derived from phyllosilicates such as potash or soda feldspar, several commercially available fluxes, and various refractive oxides for mechanical enhancement.

This is a 510(k) premarket notification for a Dental Ceramic Material (GC Initial MC, GC Initial AL, GC Initial LF). Upon reviewing the provided text, there is no detailed information regarding acceptance criteria for device performance, nor a study proving the device meets said criteria.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Stating its intended use (fabricating dental restorations).
• Mentioning its classification and product code.
• Identifying legally marketed equivalent devices (predicates).
• Asserting that it has "identical technological characteristics" to the predicate devices and "meets the appropriate ISO Standards."

Therefore, I cannot provide the requested information as it is not present in the provided 510(k) summary.

To elaborate on why this information is missing:

• Acceptance Criteria and Reported Performance: The document states the device has "identical technological characteristics" to predicates and "meets the appropriate ISO Standards." However, it does not specify which ISO standards, nor does it present specific numerical acceptance criteria or performance data from a study.
• Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set): The 510(k) summary is generally a high-level overview. Detailed study protocols, results, and specific methodologies for establishing ground truth, sample sizes for test and training sets, or expert qualifications are typically found in more comprehensive technical documentation submitted to the FDA, but not usually in the summary itself.
• Comparative Effectiveness Study (MRMC) or Standalone Performance: While the document implies equivalence to predicate devices, it does not describe a formal comparative effectiveness study involving human readers with and without AI assistance, nor does it provide standalone performance metrics for the device. Given that this is a dental ceramic material, an "AI" component or "human readers" in the context of diagnostic interpretation is not applicable here; the device itself is a material, not a diagnostic algorithm.

In summary, the provided text does not contain the specific details about acceptance criteria or a comprehensive study that you've requested beyond stating adherence to unspecified ISO standards and equivalence to predicate devices.

Ask a specific question about this device