(55 days)
Dental Blanks made from StarCeram® are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.
Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling. StarCeram® Z-Med TransColour Red is a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213. StarCeram® Z-Med TransColour Red has the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change is the addition of a new color additive.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Comply with ISO 10993-1 and ISO 10993-5 (Cytotoxicity). | All versions of the product, including StarCeram® Z-Med TransColour Red, comply with ISO 10993-1 and ISO 10993-5 (Biocompatibility and Cytotoxicity testing showed compliance). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical or performance test set, in the traditional sense involving human or animal subjects, was used for this 510(k) submission. The performance assessment was based on laboratory testing for biocompatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for biocompatibility was established by laboratory testing against recognized international standards (ISO 10993-1 and ISO 10993-5), not by expert consensus on a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set involving human interpretation or subjective assessment was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. This device is a dental material, not an AI or imaging diagnostic device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a dental material, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for performance assessment was based on laboratory test results against recognized international standards for biocompatibility (ISO 10993-1 and ISO 10993-5).
8. Sample Size for the Training Set
Not applicable. There was no "training set" in the context of an algorithm or AI model development. The product undergoes manufacturing and quality control processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for an algorithm. The "ground truth" for the material's properties (like composition and manufacturing process) is established through adherence to material specifications and quality control procedures during manufacturing.
§ 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.