# K202846: Tera Harz

- Pathway: 510(k) (Traditional)
- Applicant: Graphy, Inc.
- Decided: Jul 15, 2021 after 293 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: 7 generations back to K042819 (2004). 14 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201668: VarseoSmile Crown plus, Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG (2020) Summary page 4.

## Most influential descendants
- K213343: Saremco Print CROWNTEC (2022), 6 descendants of its own
- K233596: VarseoSmile TriniQ (2023), 3 descendants of its own
- K222877: FREEPRINT crown (2022), 2 descendants of its own
- K253053: Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (2025), 1 descendant of its own
- K233502: Tera Harz II (2023), 1 descendant of its own

## Indications for use
TERA HARZ is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations. Fabrication of TERA HARZ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.

Source page: https://510kreport.com/device/K202846
Methodology: https://510kreport.com/methodology