Premium Teeth Resin
Premium Teeth Resin (HT Bleach) for cartridge v2
10manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Tianjin (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Yongchanghe Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Suzhou Laixin 3D Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 6 |
| Xiamen Antinsky Industry Co., Ltd. | Xiamen | Fujian | Manufacturer | 6 |
Record
| Listed by | Formlabs Ohio, Inc., United States |
|---|---|
| FDA product code | PZY |
| Device type | Additively Manufactured, Preformed, Resin Denture Tooth |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3590 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K240538 |
| Record published | 2024-04-24 |
| Record revised | 2026-05-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FLPTA301 | In distribution | |
| FLPTBL01 | In distribution | |
| FLPTA201 | In distribution | |
| FLPTBL01 | In distribution | |
| FLPTA201 | In distribution | |
| FLPTB101 | In distribution | |
| FLPTB101 | In distribution | |
| FLPTA301 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| UltraPrint-Dental Denture Teeth UV | Guangzhou Heygears Imc.inc | 32 |
| Trusana | The Myerson Company Limited | 24 |
| VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 23 |
| Dima | Kulzer SRL | 20 |
| Lucitone Digital IPN 3D Premium Tooth | Dentsply Professional | 18 |
| Shining 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 14 |
| PRO3DURE GR-17.1 temporary lt | PRO3DURE Medical Gmbh | 14 |
| VarseoSmile Teeth | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | 12 |
| UltraPrint Denture Teeth UV | Guangzhou Heygears Imc.inc | 10 |
| Lucitone | Dentsply LLC | 10 |
| Glidewell™ 3DP Denture Teeth Resin | Prismatik Dentalcraft, Inc. | 8 |
| Dentca Denture Teeth | Dentca, Inc. | 7 |
Showing 12 of 99. All products under Additively Manufactured, Preformed, Resin Denture Tooth
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.