# K241131: edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK

- Pathway: 510(k) (Traditional)
- Applicant: Edelweiss Dentistry Products GmbH
- Decided: Oct 18, 2024 after 177 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K042819 (2004). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181500: BRILLIANT Crios, Coltene/Whaledent AG (2018) Summary page 6.

## Indications for use
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

Source page: https://510kreport.com/device/K241131
Methodology: https://510kreport.com/methodology