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510(k) Data Aggregation
(131 days)
Dentsply Sirona Universal Spray Glazes are aerosol glazing porcelains used to glaze high-strength glass ceramic and zirconia dental restorations. The glaze sprays are applied to restorations and fired.
The proposed devices, Dentsply Sirona Universal Spray Glazes are sprayable glazing porcelains, intended for glazing the surface of dental restorations. The glazes are supplied to dental professionals in an aerosol can. Different variations of glazes are available to meet the aesthetic preferences of dental professionals and patients. Variations with or without fluorescing agent come in a ready-to-use spray can. Variations are distinguished by the names, "Fluo" or "No Fluo" to designate the presence of fluorescing agents in the product.
No mixing is required by dental professionals as different glaze options (with or without fluorescing agent) are supplied to dental professionals in a ready-to-use form. The addition of the fluorescing agent contributes to a more aesthetic natural looking restoration.
The proposed devices, Dentsply Sirona Universal Spray Glazes, are applied on the surface of the dental restoration (example: fixed dental prostheses such as crown or bridge) in a thinuniform layer. After initial application, the restoration is then fired in a furnace for further processing. An additional layer of the proposed Dentsply Sirona Universal Spray Glazes can be applied after first firing, if necessary. If additional layer is applied, the dental restoration is placed again in the dental furnace for final firing.
This document is a 510(k) Premarket Notification for Dentsply Sirona Universal Spray Glazes. It focuses on demonstrating substantial equivalence to a predicate device, CEREC SpeedGlaze (K160099), for dental glazing purposes. The provided information does not describe a study that uses an AI/ML algorithm or requires a detailed ground truth establishment process involving multiple experts.
The acceptance criteria provided and the study conducted are for a physical material (dental glaze), not an AI/ML device. Therefore, many of the requested bullet points for an AI/ML study (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract the relevant information from the document regarding the acceptance criteria and the performance study undertaken for this dental glaze product.
Here's a breakdown of the requested information based on the provided document, highlighting what is applicable and what is not:
Device Name: Dentsply Sirona Universal Spray Glazes
Device Type: Aerosol glazing porcelains for dental restorations (a physical material, not an AI/ML device).
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are derived from the ISO 6872:2015 - Dentistry - Ceramic materials standard for Type I Class 1 materials. The reported device performance is stated as meeting these criteria.
| ISO 6872 Test Requirement | Acceptance Criteria (ISO 6872:2015 Type I Class 1) | Reported Device Performance (Dentsply Sirona Universal Spray Glazes) | Predicate Device Performance (CEREC SpeedGlaze K160099) |
|---|---|---|---|
| Uniformity | Visual inspection | Meets criteria | Not reported |
| Freedom from extraneous material | Visual inspection | Meets criteria | Not reported |
| Linear Thermal Expansion Coefficient, CTE | No specification limit; Acceptance criteria is defined as: The coefficient of thermal expansion shall not deviate by more than 0.5 x 10⁻⁶ K⁻¹ from the value stated by the manufacturer. (The specific stated value for the proposed device is not explicitly listed, but it meets the requirement relative to its own stated value.) | Meets criteria | 7.5 x 10⁻⁶ K⁻¹ ± 0.5 x 10⁻⁶ K⁻¹ |
| Glass Transition Temperature | No specification limit; Acceptance criteria is defined as: The glass transition temperature shall not deviate by more than 20°C from the value stated by the manufacturer. (The specific stated value for the proposed device is not explicitly listed, but it meets the requirement relative to its own stated value.) | Meets criteria | 490° C ± 10°C |
| Flexural Strength | 50 MPa min. | Meets criteria (>50 MPa) | >50 MPa |
| Chemical Solubility |
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(37 days)
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:
- Table of Acceptance Criteria and Reported Device Performance: Not available in this document.
- 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.
- Number of Experts and Qualifications (Ground Truth): Not applicable.
- Adjudication Method: Not applicable.
- 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.
- Standalone (Algorithm Only) Performance: Not applicable. There is no algorithm.
- Type of Ground Truth Used: Not applicable in the context of expert consensus, pathology, or outcomes data for a diagnostic algorithm.
- Sample Size for Training Set: Not applicable. There's no AI model being trained.
- How Ground Truth for Training Set was Established: Not applicable.
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