Search Results
Found 1 results
510(k) Data Aggregation
(425 days)
The C&B Ceramic material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations.
The C&B Permanent material is used for fabrications such as inlays, onlays, onlays, veneers and full crown restorations
C&B Interim material is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral lightcuring equipment.
Prevest C&B, Ceramic Resin is a light-curing material with ceramic fillers used for the 3D printing/ fabrication of Ceramic Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3 /C2 /D3 /Bleach/Extra Bleach based on the shade guide.
Prevest C&B, Interim resin is a light-curing material with glass fillers used for the 3D printing/ fabrication of long term temporary Crown & Bridge dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 /A2 /A3 /A3.5 /B1 /B2 /B3/ C2 /D3/Bleach/Extra Bleach based on the shade guide.
Prevest C&B, Permanent resin is a light-curing material with glass fillers for the 3D printing/fabrication of Permanent crown and bride dental prosthesis for use in DLP, LCD/MSLA 3D printers. It is reactive to wavelength of light between 385nm and 405nm. Recommended printers and light curing unit are Asiga Max UV, Ackuretta SOL and Acuretta Curie. It is stored in 500 and 1000ml HDPE bottles and is available in several Shades: A1 / A2 / A3 / A3.5 / B1 / B2 / B3 / C2 / D3/Bleach/Extra Bleach based on the shade guide.
These materials are used for the additive manufacturing of crown and bridge prosthesis following the workflow as depicted below:
The provided text describes a 510(k) premarket notification for three dental resin materials: C&B Ceramic, C&B Permanent, and C&B Interim. The document states that these devices are substantially equivalent to predicate devices based on various testing results.
Here's the breakdown of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document directly compares the subject devices (C&B Ceramic, C&B Permanent, C&B Interim) with predicate/reference devices against established ISO standards for certain physical parameters.
| Performance Metric | Acceptance Criteria (from ISO Standard) | C&B Ceramic Performance | C&B Permanent Performance | C&B Interim Performance |
|---|---|---|---|---|
| Flexural Strength | ISO 4049 ≥ 100 MPa ISO 10477 ≥ 50 MPa | > 100 MPa | > 100 MPa | > 100 MPa |
| Water Sorption | ISO 4049 ≤ 40 µg/mm³ ISO 10477 ≤ 40 µg/mm³ | < 40 µg/mm³ | < 40 µg/mm³ | < 40 µg/mm³ |
| Water Solubility | ISO 4049 ≤ 7.5 µg/mm³ ISO 10477 ≤ 7.5 µg/mm³ | < 7.5 µg/mm³ | < 7.5 µg/mm³ | < 7.5 µg/mm³ |
Note: The document also mentions testing for "appearance, sensitivity to ambient light, color stability, shade stability," and "biocompatibility assessment according to ISO 10993-1," but does not provide specific numerical acceptance criteria or performance results for these tests beyond stating "All test results met the criteria in standard."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "All test results met the criteria in standard" after testing protocols based on ISO 4049 and ISO 10477. These standards would typically define the required sample sizes for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The tests performed are physical and chemical property tests against ISO standards, not evaluations that require human expert judgment for "ground truth" in the typical sense of clinical or diagnostic studies.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
An adjudication method is not applicable or mentioned in this context. The testing involves laboratory measurements of material properties against predefined international standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for diagnostic medical devices where multiple human readers interpret cases with and without AI assistance. The devices described are dental resin materials, not diagnostic imaging or AI devices.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
A standalone performance study is not applicable as these are physical materials, not algorithms. The "testing summary" describes the evaluation of the materials' physical and chemical properties.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation is based on established international standards (ISO 4049 and ISO 10477) for physical and chemical properties of dental restorative materials. These standards define the acceptable ranges for metrics like flexural strength, water sorption, and water solubility. Additionally, a biocompatibility assessment according to ISO 10993-1 was conducted.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable to this submission. These are physical materials, not machine learning algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for these physical materials, this question is not applicable.
Ask a specific question about this device
Page 1 of 1