# K213343: Saremco Print CROWNTEC

- Pathway: 510(k) (Abbreviated)
- Applicant: Saremco Dental AG
- Decided: Jan 21, 2022 after 106 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: 8 generations back to K042819 (2004). 16 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202846: Tera Harz, Graphy, Inc. (2021) Summary page 4.
- K172398: DENTCA DENTURE Teeth, Dentca, Inc. (2017) Summary page 5.

## Most influential descendants
- K233596: VarseoSmile TriniQ (2023), 3 descendants of its own
- K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (2025), 1 descendant of its own
- K261356: Dura-Crown (2026), 0 descendants of its own
- K250497: Additive Manufacturing (Light Curing) Crown Bridge Resin (2025), 0 descendants of its own
- K241071: NextDent Jet Denture Base; NextDent Jet Denture Teeth (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K213343
Methodology: https://510kreport.com/methodology