LuxaPrint Ortho Plus 405
3 catalogue numbers from 171213, listed by DMG Chemisch Pharmazeutische Fabrik Gmbh, Germany, 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 | DMG Chemisch Pharmazeutische Fabrik Gmbh, Germany |
|---|---|
| FDA product code | DYT |
| Device type | Maintainer, Space Preformed, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5525 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-24 |
| Record revised | 2021-11-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Handling environment temperature 59 to 77 °F; Handling environment temperature 15 to 25 °C; Special storage condition: Store in a location that is protected against light. Always keep the container tightly sealed. |
| Distribution end date | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 171213 | Withdrawn | |
| 171260 | Withdrawn | |
| 171212 | Withdrawn |
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.