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Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include tooth anterior and posterior locations.

The CERCON® CERAM EXPRESS Ceramic System consists of a dental ceramic veneering material developed for veneering zirconium oxide substructures for fixed prosthodontics devices that include both anterior and posterior crowns and bridges. The modified device is a glass/glass-ceramic mixture used to veneer zirconia substrates in a medium-pressure. lost-wax injection molding (pressing) process. The modified device consists of a translucent material and an opaque material.

This 510(k) K041707 submission focuses on a dental ceramic veneering material (CERCON® CERAM EXPRESS Ceramic System) and demonstrates substantial equivalence to a predicate device, Cercon® Ceram S Porcelains (K022796).

The provided text does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology (sample size, expert qualifications, adjudication, etc.) of such a study.

Instead, the submission primarily focuses on:

• Device Description and Intended Use: CERCON® CERAM EXPRESS Ceramic System is a glass/glass-ceramic mixture for veneering zirconia substructures in fixed prosthodontics.
• Technological Characteristics: It's a modification of an existing device (Cercon® Ceram S Porcelains, K022796) with changes to formulation, material form, and processing.
• Basis for Substantial Equivalence: The manufacturer asserts substantial equivalence based on the prior use of components in legally marketed devices, similarity in formulations, and data regarding modifications. This implies that the modifications did not introduce new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document.

It's important to understand that for materials like this, "performance" is often demonstrated through mechanical and biocompatibility testing (e.g., flexural strength, bond strength, cytotoxicity) rather than clinical studies with human readers or AI algorithms as would be relevant for diagnostic imaging devices. Such tests would typically compare the modified device's properties to the predicate device or established standards. However, the details of these tests are not present in the provided summary.

Here's what can be inferred or stated about what is NOT present:

1. Table of Acceptance Criteria and Reported Device Performance: Not available in this document.
2. Sample Size and Data Provenance (Test Set): Not applicable or not reported for the type of comparison made. There is no "test set" in the context of human readers or AI performance.
3. Number of Experts and Qualifications (Ground Truth): Not applicable.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not conducted or reported. This device is a material, not a diagnostic tool requiring human reader interpretation or AI assistance in that sense.
6. Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.
7. Type of Ground Truth Used: Not applicable in the context of expert consensus, pathology, or outcomes data for a diagnostic algorithm.
8. Sample Size for Training Set: Not applicable. There's no AI model being trained.
9. How Ground Truth for Training Set was Established: Not applicable.

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Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.

CERCON® CERAM S PORCELAIN is a dental ceramic veneering material developed for veneering Cercon zirconia or an equivalent zirconium oxide substructure for fixed prosthodontics devices that include both anterior and posterior crowns/bridges. The CERCON® CERAM S PORCELAIN System consists of Dentin/Transparent/Incisal, Liner/Opaque, Shoulder, and Correction/Glaze/Stain Porcelains. The final restoration matches more shades than the predicate device.

This document is a 510(k) summary for a dental ceramic veneering material named CERCON® CERAM S PORCELAIN. It does not contain information about a study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the context of device performance metrics typically associated with AI/ML devices or diagnostic tools.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Cercon® Ceram K011333) based on:

• Device Description: It describes the use of the new porcelain for veneering zirconia substructures in fixed prosthodontic devices.
• Intended Use: It specifies the use on zirconia for single tooth or bridge type restorations in anterior and posterior locations.
• Technological Characteristics: It highlights that CERCON® CERAM S PORCELAIN is a modification of the predicate device with minor formulation changes.
• Biocompatibility: It states that the device was evaluated and passed biocompatibility testing for cytotoxicity.
• Components: It mentions that all components have been used in legally marketed devices.

The conclusion is that the prior use of components, similarity in formulation, and biocompatibility data support the safety and effectiveness of the new device.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document is a regulatory submission for a material, not a diagnostic or AI-powered device that would typically involve such performance studies.

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