Search Results
Found 1 results
510(k) Data Aggregation
(105 days)
CERCON HT
Cercon® ht is indicated in the anterior and posterior segments for:
- crowns
- telescopic primary crowns
- multi-unit bridges (with no more than two pontics between abutment crowns)
Cercon® ht can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns the substructure is not veneered.
Cercon ht is a ceramic composed of partially sintered yttria stabilized zirconia powder (Y-TZP). It is supplied to the dental laboratory as a blank and then processed in the dental-laboratory by machining and subsequent sintering to full density. It can be veneered with a dental veneering ceramic or can be used as anatomically shaped full-contour crown or bridge without veneering. It is designed for anterior and posterior locations as a substructure (framework) for single-tooth or bridge type restorations. It can also be used for the preparation of telescopic primary crowns.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Flexural Strength) | Similar to predicate device (Cercon Base) | "material has the same mechanical (flexural strength)... as the predicate device." |
| Chemical Stability (Solubility) | Similar to predicate device (Cercon Base) | "material has the same... chemical stability (solubility) as the predicate device." |
| Wear (of unveneered material itself) | Significantly lower abrasion compared to conventional veneering porcelain | "significantly lower compared to conventional veneering porcelain." |
| Wear (of antagonist teeth opposed to unveneered material) | Significantly lower abrasion compared to conventional veneering porcelain | "significantly lower compared to conventional veneering porcelain." |
| Fit of Large Bridges | Comparable to conventional metal cast frameworks | "comparable to conventional metal cast frameworks." |
| Fitting Accuracy of Telescopic Primary Crowns | Good fitting accuracy | "a good fitting accuracy... is achieved." |
| Surface Quality of Telescopic Primary Crowns | Good surface quality | "a good surface quality is achieved." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test (flexural strength, solubility, wear tests, fit tests, telescopic primary crown tests). The data provenance is not specified regarding country of origin; however, the tests were "Non-Clinical Performance Data" and "bench tests and professional evaluations" performed to demonstrate substantial equivalence to a predicate device. This suggests lab-based, retrospective testing rather than prospective clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth. It mentions "professional evaluations" in the context of proving substantial equivalence but does not detail the methodology for these evaluations.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given the non-clinical nature of the tests, adjudication for human-based assessment as seen in clinical trials would not typically apply. The evaluation seems to rely on direct measurement and comparison to established benchmarks or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies solely on non-clinical performance data (mechanical and chemical property testing, wear tests, fit tests). The document explicitly states: "Clinical Performance Data. Not applicable."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. Cercon ht is a physical dental material (zirconia ceramic) and not a software algorithm or AI device that would have "standalone" performance in the context of human-in-the-loop assessments.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests appears to be based on:
- Established physical and chemical properties: Standardized measurements for flexural strength and solubility.
- Comparative data against predicate device: Evaluating if Cercon ht performs "the same as" the predicate Cercon Base for mechanical and chemical properties.
- Benchmarks against conventional materials: Comparing wear to "conventional veneering porcelain" and fit to "conventional metal cast frameworks."
- Qualitative assessments of fit and surface quality: "good fitting accuracy and a good surface quality."
8. The Sample Size for the Training Set
This question is not applicable. Cercon ht is a physical dental material, not an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical dental material.
Ask a specific question about this device
Page 1 of 1