Search Results
Found 1 results
510(k) Data Aggregation
(177 days)
edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK
T-BLOCK and C-BLOCK are used for the following indications
- -Crowns, inlays, onlays and veneers
- -Implant-supported crowns
The i-BLOCK is used for the following indication:
- Implant-supported crowns -
The edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM Block are hybrid glass blocks used for the fabrication of indirect single-tooth restorations using CAD/CAM technology. The edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK are available in the three different variants T-BLOCK and i-BLOCK and five shades.
T-BLOCKs are highly translucent blocks that mimic the optical properties of natural enamel. C-BLOCKs are high chromatic blocks corresponding to the color shades A0, A1, A2 and A3. i-BLOCKs are highly translucent and highly chromatic blocks, which have a pre-produced Ti-base interface.
The uniqueness of the edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK lies in the manufacturing process, in which a hybrid glass block is produced by the patented process of vitrification and laser sintering. As a result, the edelweiss CAD/CAM BLOCK and the Ceramir CAD/CAM BLOCK combines the properties of the current CAD/CAM systems in a single block. It has properties comparable to those of feldspar glass-ceramics.
The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating "substantial equivalence" of a new medical device to a predicate device already on the market. This type of submission is not a traditional clinical study or performance evaluation with acceptance criteria and reported device performance in the way a diagnostic AI device or drug might be. Instead, it relies on demonstrating that the new device has similar technological characteristics and performs similarly to known devices, implying it is equally safe and effective.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this document. I will fill in the available information and explicitly state when information is not present or not relevant to this type of regulatory submission.
1. A table of acceptance criteria and the reported device performance
For a 510(k) for dental materials like this, "acceptance criteria" are typically defined by recognized consensus standards and a comparison to the predicate device. The "reported device performance" is essentially demonstrating that the new device meets or exceeds the predicate's performance in key physical properties.
| Acceptance Criterion (Implicitly defined by comparison to predicate and standards) | Reported Device Performance (New Device: edelweiss CAD/CAM BLOCKs/Ceramir CAD/CAM BLOCKs) | Predicate Device (BRILLIANT Crios) Performance | Result (Compared to Predicate) |
|---|---|---|---|
| Regulation Number: §872.3690 | §872.3690 | §872.3690 | Substantially Equivalent |
| Class: II | II | II | Substantially Equivalent |
| Product Code: EBF | EBF | EBF | Substantially Equivalent |
| Indications for Use: (Crowns, inlays, onlays, veneers, implant-supported crowns) | T-BLOCK and C-BLOCK: Crowns, inlays, onlays, veneers, implant-supported crowns; i-BLOCK: Implant-supported crowns | Crowns, inlays, onlays, veneers, implant-supported crowns | Substantially Equivalent (same intended use and permanent tooth restorations) |
| Physical State: Cured blocks | Cured blocks | Cured blocks | Substantially Equivalent |
| Structure: Polymer resin / ceramic hybrid composite | Polymer resin / ceramic hybrid composite | Polymer resin composite | Substantially Equivalent |
| Resin Matrix Monomers: (Contains Bis-GMA and UDMA) | Bis-GMA, UDMA, EBPADMA | Bis-GMA, Bis-EMA, TEGDMA, UDMA | Substantially Equivalent (both contain Bis-GMA and UDMA) |
| Filler: Silica, barium glass | Silica, barium glass | Silica, barium glass | Substantially Equivalent |
| Sizes: 12, 14 | 12, 14 | 12, 14 | Substantially Equivalent |
| Flexural Strength: (Compared to predicate, e.g., ~198 MPa) | 200 (MPa) | 198 (MPa) | Substantially Equivalent |
| Flexural Modulus: (Compared to predicate, e.g., ~10.3 GPa) | 20 (GPa) | 10.3 (GPa) | Substantially Equivalent |
| Compressive Strength: (Compared to predicate, e.g., ~426 MPa) | 550 (MPa) | 426 (MPa) | Substantially Equivalent |
| Packaging: Mandrel mounted; five to a box | Mandrel mounted; five to a box | Mandrel mounted; five to a box | Substantially Equivalent |
| Usage: Single Patient, multiple use | Single Patient, multiple use | Single Patient, multiple use | Substantially Equivalent |
| Sterility: Non-Sterile | Non-Sterile | Non-Sterile | Substantially Equivalent |
| Biocompatibility: Conforms with ISO 10993-1 | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 | Substantially Equivalent |
| Performance: Conforms with ISO 4049, ISO 10477 | Conforms with ISO 4049, ISO 10477 | Conforms with ISO 4049 | Substantially Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical performance testing of material properties, not a clinical trial with a "test set" of patient data. The "test set" would refer to the samples of the material used for physical and chemical testing. The sample sizes for these material tests are not explicitly stated in this summary, but they would have been conducted according to the relevant ISO standards (e.g., ISO 4049, ISO 10477) for mechanical properties, which specify minimum sample numbers. The data provenance would be from laboratory testing conducted by or on behalf of edelweiss dentistry products gmbh, likely in Austria or Germany (where the applicant and correspondent are located). This would be prospective laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert readers or "ground truth" established by experts in the context of medical image analysis or diagnosis. The "ground truth" for the material properties are the measurements obtained through standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is relevant for this type of material testing. The results are from direct physical and chemical measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-based device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance relies on measurements derived from recognized consensus standards and internal test protocols for physical and biocompatibility properties (e.g., flexural strength, compressive strength, biocompatibility according to ISO 10993-1). The "ground truth" is therefore objective laboratory measurement data.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Ask a specific question about this device
Page 1 of 1