TPA/Nance Combo
Catalogue number 5600025, listed by Five Star Orthodontic Laboratory & Supply, Inc., United States, under Maintainer, Space Preformed, Orthodontic. 18 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (5), Guangdong (5), Jiangsu (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Sezen Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang | Sichuan | Contract manufacturer | 4 |
| Dongguan Gooodol Mould & Product Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Zhejiang Longmed Medical Technology Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 16 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
Showing 12 of 18. All 18 manufacturers in China registered for Maintainer, Space Preformed, Orthodontic
Record
| Listed by | Five Star Orthodontic Laboratory & Supply, Inc., United States |
|---|---|
| FDA product code | DYT |
| Device type | Maintainer, Space Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5525 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5600025 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Denovo chairside space maintainer band | Denovo Dental Inc | 78 |
| 3D | RMO | 69 |
| Denovo chairside space maintainer crown | Denovo Dental Inc | 56 |
| e-Space Maintainer | Kids-E-Dental LLP | 50 |
| Bondable Retainer | American Orthodontics | 40 |
| NuSmile Ucsm Replacement Band | Nusmile, Ltd | 39 |
| Vertex-Dental BV | Vertex-Dental B.V. | 37 |
| Taglus | GC Orthodontics America Inc. | 13 |
| Maintainer, Space Preformed, Orthodontic | Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. | 9 |
| Denovo Space Maintainer wire loop | Denovo Dental Inc | 8 |
| Reveal® | Ortho Organizers, Inc. | 8 |
| dentona vivapink | Dentona AG | 7 |
Showing 12 of 114. All products under Maintainer, Space Preformed, Orthodontic
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.