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The C-30 Crowns are indicated for the use as a permanent Posterior Dental Crown

The C-30 Crown Kit is a permanent tooth solution for single-unit restoration, adhesively cemented. The C-30 Crown Kit contains 3 components required for the chairside direct assembly of a posterior permanent crown.

1. The C-30 Sleeve, manufactured from VarseoSmile Crown Plus the 510(k) cleared (K201668) material has an external aspect that matches the internal aspect of the C-30 Crown, also manufactured with the same VarseoSmile Crown Plus (K201668) 510(k) cleared material. This material is a light cured, ceramic filled, methacrylate-based resin for the production of permanent single crowns. The sleeve is used as a containment vessel holding the 510(k) cleared Visalys CemCore, Visalys Cem Core Try In Paste (K191527) Adhesive Cement & CoreBuild-up which surrounds the prepared tooth created by the dentist. This match of the two units assures a perfect fit with a minimal gap of 5-15 microns between the C-30 Crown and the C-30 Sleeve.
2. The Visalys CemCore, Visalys Cem Core Try In Paste. (K191527) is used to treat the bonding surface of the sleeveand the Visalys CemCore, Visalys Cem Core Try In Paste. (K191527) is used to fill up the gap between the prepped tooth structure and the C-30 Sleeve. Once bonded and cured, the process continues.
3. The C-30 Crown now fits perfectly over the C-30 Sleeve and is bonded in place with the Visalys CemCore, Visalys Cem Core Try In Paste. (K191527) used consistent with its instructions for use.

The provided text is a 510(k) summary for the Perfect Fit Crowns LLC C-30 Crown Kit. It describes the device, its components, and how it is substantially equivalent to predicate devices. However, this document does not contain any information regarding acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to existing cleared devices based on material composition, intended use, and technological characteristics, rather than reporting on a clinical or performance study with defined acceptance criteria.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving the device meets them from the provided text. The document states:

• "The submitted non-clinical testing for the VarseoSmile Crown Plus (K201668) applies to the same material characteristics and validates intended use of the Subject." (Page 6)
• "The Visalys CemCore, Visalys Cem Core Try In Paste (K191527) included with the C-30 Crown Kit is in the original manufacturer's packaging and all non-clinical data submitted in the K191527 documents provided validating the material's intended use." (Page 6)
• "In all cases, the Subject using the Predicate material in their devices have been demonstrated to be safe and effective for their intended use through non-clinical performance testing." (Page 5)
• "Any differences have been mitigated by demonstration of the Subject device to be suitable for intended use through Predicate additional non-clinical performance testing." (Page 6)

These statements indicate reliance on previously submitted non-clinical data for the predicate materials used in the C-30 Crown Kit, rather than a new study specific to the C-30 Crown Kit reporting on acceptance criteria for its direct performance as a final device assembly. No specific performance metrics, sample sizes, ground truth establishment, or expert involvement for a study of the C-30 Crown Kit are detailed in this document.

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