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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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(99 days)
CELTRA Press is an all-ceramic system for the creation of Occlusal veneers Thin veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior and posterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.
CELTRA Press is a high-strength zirconia-reinforced lithium silicate glass ceramic material that can be used for the fabrication of highly aesthetic all-ceramic restorations by using the hot-pressing technique in dental labs. The homogeneous, industrially produced ingots are available in both high and low translucency for full-contour application. They are pressing furnaces using press investments material which do not form surface reaction layer to obtain tooth-colored, highly aesthetic, all-ceramic restorations. Subsequently, CELTRA Press may be veneered, stained and/or glazed with compatible CELTRA Press veneering porcelains.
The provided document describes the mechanical properties and biocompatibility of a dental ceramic material called CELTRA Press, not an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and ground truth for training set) are not applicable to this submission.
However, I can extract the relevant information regarding the acceptance criteria and the studies performed to demonstrate the device meets these criteria.
Acceptance Criteria and Reported Device Performance for CELTRA Press
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Proving Performance |
|---|---|---|---|
| Material Classification | Conforms to ISO 6872:2015, Type II, Class 4a (Monolithic ceramic for three-unit prostheses involving molar restoration) and Class 4b (Partially or fully covered substructure for three-unit prostheses involving molar restoration) | CELTRA Press is a Type II Class 4 device. | Non-clinical bench testing in accordance with ISO 6872:2015. |
| Flexural Strength | Minimum mean flexural strength of 500 MPa for Type II Class 4 materials (as per ISO 6872:2015) | Meets the requirement for Type II Class 4 materials. | Non-clinical bench testing in accordance with ISO 6872:2015. |
| Chemical Solubility | Conforms to ISO 6872:2015 requirements | Conforms to ISO 6872:2015 | Non-clinical bench testing in accordance with ISO 6872:2015. |
| Coefficient of Thermal Expansion (CTE) | Conforms to ISO 6872:2015 requirements | Conforms to ISO 6872:2015 | Non-clinical bench testing in accordance with ISO 6872:2015. |
| Radioactivity | Conforms to ISO 6872:2015 requirements | Conforms to ISO 6872:2015 | Non-clinical bench testing in accordance with ISO 6872:2015. |
| Biocompatibility | Conforms to ISO 10993-1, 10993-5, and 10993-18 | Results of testing support the biocompatibility of CELTRA Press. | Toxicological testing completed according to ISO 10993-1, 10993-5, and 10993-18. |
Breakdown of Study Information:
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Sample size used for the test set and the data provenance: Not applicable to this type of device (material properties are tested, not a diagnostic algorithm). The document states "non-clinical bench testing conducted." Specific sample sizes for each physical property test are not detailed in this summary. Data provenance is implied to be from laboratory testing performed by the manufacturer or a contracted lab.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by objective, standardized physical and chemical measurements according to ISO standards, not expert consensus.
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Adjudication method for the test set: Not applicable for material property testing.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML powered medical device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered medical device.
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The type of ground truth used:
- For Physical Properties (Flexural Strength, Chemical Solubility, CTE, Radioactivity): The ground truth is defined by the objective measurement standards and thresholds specified in ISO 6872:2015 (Dentistry - Ceramic materials).
- For Biocompatibility: The ground truth is established by the accepted methodologies and endpoints defined in ISO 10993-1, 10993-5, and 10993-18 (Biological evaluation of medical devices).
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The sample size for the training set: Not applicable. This is not an AI/ML powered medical device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML powered medical device.
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