# K233502: Tera Harz II

- Pathway: 510(k) (Traditional)
- Applicant: Graphy, Inc.
- Decided: Nov 1, 2023 after 1 day
- 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). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 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.

## Most influential descendants
- K250763: Reon (2025), 0 descendants of its own

## Indications for use
TERA HARZ II is intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The TERA HARZ II 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 II requires a computer-aided and manufacturing (CAD/CAM) system that includes the following : scanner, design software, additive printer, and post-cure unit. Brand Type Design : 3 Shape A/S TRIOS 3 Basic Instraoral scanner 3 Shape A/S 3Shape dental system Design software Additive Manufacturing system : 3D Printer UNIZ NBEE SprintRay Inc. Pro 95 Post-Curing : Post-cure unit CureM U102H TERA HARZ CURE THC

Source page: https://510kreport.com/device/K233502
Methodology: https://510kreport.com/methodology