Vertex-Dental BV
3D printing material for try-in devices
5manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Zhejiang (1). 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 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Riton 3D Technology Co., Ltd. | Guangzhou | Guangdong | Repacker / relabeller | 9 |
| Guangzhou Heygears Imc.inc | Guangzhou | Guangdong | Specification developer | 8 |
| Suzhou Laixin 3D Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 6 |
Record
| Listed by | Vertex-Dental B.V., Netherlands |
|---|---|
| FDA product code | EEA |
| Device type | Plate, Base, Shellac |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6200 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-04-19 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NDTRPI01000_01 | In distribution | |
| NDTRPI01000_01 | In distribution | |
| NDTRPI01000 | In distribution | |
| NDTRPI01000 | In distribution | |
| NDTRPI01000_01 | In distribution | |
| NDTRPI01000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Try-in | Shandong Huge Dental Material Corporation | 5 |
| Ceramill | Vertex-Dental B.V. | 3 |
| LuxCreo Dental Night Guard Resin | Luxcreo Inc. | 3 |
| printodent GR-21.1 Try-In | PRO3DURE Medical Gmbh | 3 |
| PRO3DURE GR-21 Try-In | PRO3DURE Medical Gmbh | 3 |
| 3Delta Try-In | Deltamed Gmbh | 2 |
| Nobilium | Cmp Industries, LLC | 2 |
| P pro Try-In | Deltamed Gmbh | 1 |
| Cavex Baseplate mica-free lowers | Cavex Holland B.V. | 1 |
| Cavex Baseplate uppers Double Thickness | Cavex Holland B.V. | 1 |
| Ucan Print Try-In | PRO3DURE Medical Gmbh | 1 |
| RS Try-In | Deltamed Gmbh | 1 |
Showing 12 of 27. All products under Plate, Base, Shellac
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.