(135 days)
Glazing of individually designed dental restorations from dental ceramics.
The CEREC SpeedGlaze Spray is used for coating dental restorations made from Sirona CAD/CAM materials. It is administered extra-orally and is indicated for crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.
The CEREC SpeedGlaze Spray is used to glaze dental restorations made from the Sirona CAD/CAM materials CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The spray meets the requirements of the ISO 6872:2008 "Dentistry - Ceramic materials". The product consists of a coated aluminum can cap, filled with a glaze and a valve and a spray nozzle, for applying the glaze. The CEREC Speed Glaze Spray is suitable for the coating of dental restorations from the Sirona CAD/CAM materials: CEREC Zirconia, inCoris TZI C, CEREC Blocs C, CEREC Blocs C PC and CEREC Blocs C In. The CEREC SpeedGlaze spray has to be administered extraorally.
It is indicated for the following parts of dentistry:
- crowns, inlays, onlays, partial crowns and bridges in the anterior and posterior tooth region.
The product has 8 components as shown below:
- Can: Aluminum monobloc spray can
- Valve: For releasing the contents when engaged
- Can cap PP - Polypropylene, Plastic
- Spray nozzle: For spraying onto restoration
- 14mm Glass balls For mixing of the components before spraying
- Glaze Ceramic Silicate glass
- Instruction for use Instructions for use document
- Folding carton Package
The document describes the CEREC SpeedGlaze, a device used for glazing dental restorations, and its substantial equivalence to a predicate device (Nova Ceramic Spray Glaze). The information provided focuses on non-clinical performance data.
Acceptance Criteria and Device Performance:
| Property | Acceptance Criteria (Protocol) | Reported Device Performance/Result |
|---|---|---|
| Physical state | Visual inspection | Passed |
| Granulometry | Laser particle sizer | Passed |
| Appearance (color, transparency) | Visual inspection | Passed |
| Firing Temperature | Internal protocol | Passed |
| Coefficient thermal expansion | ISO EN DIN 6872 | Passed |
| Transformation temperature | ISO EN DIN 6872 | Passed |
| Bending strength | ISO EN DIN 6872 | Passed |
| Chemical solubility | ISO EN DIN 6872 | Passed |
| Radioactivity | ISO EN DIN 6872 | Passed |
| Cytotoxicity | ISO EN DIN 10993-5 | Passed |
| Thermal Shock Test of Glaze | Internal protocol | Passed |
| Chemical Analysis | DIN 15169 | Passed |
Study Details:
The provided document describes non-clinical tests rather than a study with a test set of data as one might expect for an AI/device performance evaluation that applies to imaging or diagnostic devices. Instead, it describes laboratory-based performance testing of the physical, chemical, and biological properties of the CEREC SpeedGlaze.
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Sample size used for the test set and the data provenance: Not explicitly an "imaging test set" in the traditional sense. The device itself (CEREC SpeedGlaze) and its components were subjected to various laboratory tests. The document does not specify the number of samples or batches tested for each property, nor does it mention data provenance (e.g., country of origin, retrospective/prospective).
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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. The "ground truth" here is based on established ISO and DIN standards for material properties, not expert interpretation of cases. The tests are laboratory-based measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests are objective measurements against defined standards.
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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 device is a dental material (glaze), not an AI-assisted diagnostic or imaging system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a material testing, not an algorithmic performance evaluation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or reference for these performance tests are the requirements and methodologies stipulated in international standards such as ISO 6872, ISO 10993-5, and DIN 15169. For example, cytotoxicity is determined by meeting the criteria of ISO 10993-5, and bending strength by ISO 6872.
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The sample size for the training set: Not applicable. This device is a material, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established: Not applicable, as there is no training set.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.