Tera Tainer
Tera Tainer can be used in combination with all laser and DLP,SLA and LCD based 3D printers which support dental materials. Tera TainerR 3D-printing material is a preformed tooth positioner…
Tera Tainer can be used in combination with all laser and DLP,SLA and LCD based 3D printers which support dental materials. Tera TainerR 3D-printing material is a preformed tooth positioner and retainer after orthodontic plan finished. indicated for the manufacturing of orthodontic retainer. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device.
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (6), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
| Huizhou Gold Rose Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 19 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Hubei YJT Intelligent Technology Group Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 12 |
Showing 12 of 19. All 19 manufacturers in China registered for Positioner, Tooth, Preformed
Record
| Listed by | Graphy Inc., South Korea |
|---|---|
| FDA product code | KMY |
| Device type | Positioner, Tooth, Preformed |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5525 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2026-05-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 25 °C; Storage environment humidity 30 to 75 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TA-83 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amcop Bioactivator | Micerium SPA | 265 |
| LMDental | LM-Dental | 195 |
| Myobrace® | Myofunctional Research Corp. PTY. Ltd. | 123 |
| Pre-Finisher | TP Orthodontics, Inc. | 120 |
| Drufosoft® | Dreve Dentamid Gmbh | 93 |
| Proform | Keystone Industries | 88 |
| Orthocryl® | Dentaurum GmbH & Co. KG | 65 |
| Atmos | American Orthodontics | 45 |
| Duran® | Scheu-Dental Gmbh | 40 |
| Biolon | Dreve Dentamid Gmbh | 38 |
| Positioner, Tooth, Preformed | Dentaurum GmbH & Co. KG | 31 |
| The Trainer System™ | Myofunctional Research Corp. PTY. Ltd. | 30 |
Showing 12 of 220. All products under Positioner, Tooth, Preformed
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.