Tera Harz II
Tera Harz II is a light-cured methacrylate-based resin for CAD/CAM fabrication of indirect anterior and posterior dental restorations. Applications include temporary or permanent crowns,…
Tera Harz II is a light-cured methacrylate-based resin for CAD/CAM fabrication of indirect anterior and posterior dental restorations. Applications include temporary or permanent crowns, bridges, inlays, onlays and veneers, including occlusal surfaces.
A compatible three-dimensional printer builds the prescribed restoration in successive layers from a digital design. The printed article then receives ultraviolet post-curing for final polymerization.
Listed Item
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.
Digital Workflow and Supply
A scanner, design software, additive printer and post-cure unit are required separately. The resin is supplied in black 1,000 g HDPE bottles in multiple tooth shades. The dental clinician prescribes the restoration and the digital file defines its final contour.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Graphy Inc., South Korea |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K233502 |
| Record published | 2024-05-09 |
| Record revised | 2025-08-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date |
| Storage | Storage environment temperature 59 to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR-23A3-1000 | In distribution | |
| BR-23OM1-1000 | In distribution | |
| BR-23B1-1000 | In distribution | |
| BR-23D1-1000 | In distribution | |
| BR-23OM3-1000 | In distribution | |
| BR-23A1-1000 | In distribution | |
| BR-23B3-1000 | In distribution | |
| BR-23OM2-1000 | In distribution | |
| BR-23C2-1000 | In distribution | |
| BR-23D2-1000 | In distribution | |
| BR-23C3-1000 | In distribution | |
| BR-23A2-1000 | In distribution | |
| BR-23D3-1000 | In distribution | |
| BR-23B2-1000 | In distribution | |
| BR-23C1-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233502 | 2023-11-01 |
| K202846 | 2021-07-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.