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510(k) Data Aggregation
(25 days)
Dental Zirconia Ceramic
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Co3O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has 19 models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.
I'm sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a "Dental Zirconia Ceramic" device. This document does not contain the specific information you requested regarding acceptance criteria and a study proving device performance, particularly related to AI/software aspects.
The document discusses:
- Device Name: Dental Zirconia Ceramic
- Regulation Number: 21 CFR 872.6660 (Porcelain Powder For Clinical Use)
- Regulatory Class: Class II
- Product Code: EIH
- Intended Use: Dental restorations using CAD/CAM or manual milling machines.
- Non-clinical Test Conclusion: Physical and mechanical properties evaluated according to ISO 6872:2015/AMD 1:2018 and ISO 13356:2015. Biocompatibility testing performed.
- Technological Characteristics: Yttria-stabilized zirconia composition, inorganic pigments for color.
- Comparison to Predicate Device: Notes similarities in intended use, patient population, principle of operation, and mechanism of action. Highlights differences in the number of models offered (new models added).
- Conclusion: Substantial equivalence to the legally marketed predicate device based on comparison and analysis.
However, it does not provide:
- A table of acceptance criteria and reported device performance in a measurable format for software or AI.
- Sample size used for the test set and data provenance for a software algorithm.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study information (human readers improve with/without AI assistance).
- Standalone (algorithm-only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The device described is a ceramic material for dental restorations, not an AI or software-based medical device. Therefore, the specific types of studies and criteria you're asking about (MRMC, standalone performance, training/test sets, ground truth establishment for AI) are not present in this document.
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(97 days)
Dental Zirconia Ceramic
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe203+Er2O3+C03O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has six models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015 Dentistry: Ceramic Materials.
This FDA 510(k) summary describes a Dental Zirconia Ceramic device (K222626) and its comparison to a predicate device (K183304). The submission focuses on non-clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dental Zirconia Ceramic are based on the requirements specified in ISO 6872:2015 Dentistry - Ceramic materials. The reported device performance is presented as test results against these criteria.
| Test Item | Acceptance Criteria (from ISO 6872:2015) | Reported Device Performance (Worst Case/Range) |
|---|---|---|
| Uniformity | Uniform | Uniform (for all models: Multilayer-3D, UTC, UTM, Multilayer-3D pro, SHTPC, SHTPM) |
| Freedom from extraneous materials | Free from extraneous materials | Free from extraneous materials (for all models) |
| Radioactivity (Bq.g-1) | ≤ 1.0 (from comparison table, implied acceptance) |
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(58 days)
Dental Zirconia Ceramic
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed thought dental laboratories or by dental professionals.
The subject device, Dental Zirconia Ceramic, are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all ceramic restorations such as veneers, inlay/ onlay, partial crowns,anterior crowns, posterior crowns. The ceramics material is composed of ZrO2, Y2O3 Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface, totally 16 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2,C3,C4,D2,D3,and D4), with the addition of very small amount (
This document is a 510(k) Premarket Notification from the FDA regarding a dental device. It does not describe a study that uses AI or machine learning technology to interpret medical images or other diagnostic data. Instead, it concerns a physical dental material (Zirconia Ceramic) and its comparison to a predicate device based on physical and chemical properties.
Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test set, data provenance, number of experts establish ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance for the non-clinical tests that were performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Uniformity | Uniformly dispersed inorganic pigment(s) to produce color. | Product uniformity is qualified. Pass |
| Freedom from extraneous materials | Free from extraneous materials. | No extraneous materials. Pass |
| Radioactivity | Activity concentration of 238U not more than 1.0 Bq/g. | There was no activity detected. Pass |
| Flexural strength | Not less than 900 MPa. | Average 943.1 MPa. Pass |
| Linear thermal expansion coefficient | (10.5 ± 0.5) × 10^-6 K^-1. | Average 10.47 × 10^-6. Pass |
| Chemical solubility | Not more than 2000 µg/cm^2. (Note: Comparison table states |
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