(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 |
§ 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.