# K232050: saremco print BRIDGETEC

- Pathway: 510(k) (Abbreviated)
- Applicant: Saremco Dental AG
- Decided: Nov 14, 2023 after 127 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: 9 generations back to K042819 (2004). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213343: Saremco Print CROWNTEC, Saremco Dental AG (2022) Summary page 5.

## Indications for use
saremco print BRIDGETEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print BRIDGETEC material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. saremco print BRIDGETEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.

Source page: https://510kreport.com/device/K232050
Methodology: https://510kreport.com/methodology