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510(k) Data Aggregation
(177 days)
Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System.
Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.
Amber Mill Series and Amber Press Series are a lithium silicate ceramic to be supplied in the form of Ingots & Blocks. Amber Mill can be fabricated using CAD/CAM technologies and Amber Press can be fabricated using hot press technique.
This dental material is glass type material used for aesthetic purposes of veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li20, K20, P205, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
The subject device offers 31 different size/shape series and each series offers 45 different shades. 31 different sizes are to be used with various equipments for CAD/CAM milling or hot press and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patients tooth colors.
Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Title | Test Standard | Acceptance Criteria (Requirement/Criteria) | Reported Device Performance (Test Result) |
|---|---|---|---|
| Visual Inspection | N/A | There shall be no extraneous materials, distributing at use when assessed by visual inspection. | There were no extraneous materials, distributing at use when assessed by visual inspection. (PASS) |
| Size Test Report | N/A | The size tolerance should be within +/- 2mm. | PASS |
| Package Test Report | N/A | There shall be no breakage, no crack, no pollution of foreign body and no problem of use in product. | There was no breakage, no crack, no pollution of foreign body and no problem of use in product. (PASS) |
| Uniformity Test Report | ISO 6872 | Colorants shall be dispersed uniformly on the block. | Colorants were dispersed uniformly on the block. (PASS) |
| Foreign Body Test Report | ISO 6872 | It shall be free from extraneous materials. | They were free from extraneous materials. (PASS) |
| Chemical Solubility Test Report | ISO 6872 | less than 100 µg/cm² | PASS |
| Flexural Strength Test Report | ISO 6872 | Over 300 MPa | PASS |
| Radioactivity Test Report | ISO 6872 | U238: Less than 1.0 Bq/g | PASS |
| Linear Thermal Expansion Test Report | ISO 6872 | 10.0 +/- 0.5 10^-6 K^-1 | PASS |
| Glass Transition Temperature Test Report | ISO 6872 | 550 +/- 20 °C | PASS |
| Genotoxicity | ISO 10993-3 | < 2.0 | PASS |
| Cytotoxicity test | ISO 10993-5 | ≥ 70% | PASS |
| Irritation test | ISO 10993-10 | No mutation | PASS |
| Sensitization test | ISO 10993-10 | < 1.6 | PASS |
| Systemic toxicity (oral) test | ISO 10993-11 | No abnormality and death | PASS |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each of the non-clinical tests or the data provenance (e.g., country of origin, retrospective/prospective). The tests listed are primarily bench tests on the material itself, not clinical studies involving human subjects or real-world data collection. The tests seem to be conducted in a laboratory setting as part of the material characterization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The tests performed are objective, quantitative material property tests according to international standards (ISO). Ground truth in this context is established by the specified standards and measured values, not by expert consensus or interpretation of images/cases.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the tests are objective material property measurements against defined standards. There is no need for an adjudication method for interpreting results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is a dental material, not an AI-assisted diagnostic or imaging device used by human readers for interpretation.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a dental material. The performance tests are specific to the physical, chemical, and biological properties of the material itself.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on the objective requirements and criteria specified in international standards (ISO 6872, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11) and internal bench testing requirements. This is essentially definitive physical/chemical/biological measurement standards.
8. Sample Size for the Training Set:
Not applicable. This is a material, not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this device.
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