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510(k) Data Aggregation
(425 days)
Freeprint Temp K200273
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 |
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