DTX Studio™ Lab
DTX Studio Lab 1.12 for Windows 64-bit
2manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
Record
| Listed by | Nobel Biocare AB, Sweden |
|---|---|
| FDA product code | PNP |
| Device type | Dental Abutment Design Software For Dental Laboratory |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K181932 |
| Record published | 2021-05-28 |
| Record revised | 2022-02-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2019-08-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1.12 | In distribution | |
| 1.10 | In distribution | |
| 1.11 | In distribution | |
| 1.9 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IPD | Implant Protesis Dental 2004 SL | 317 |
| BruxZir® | Prismatik Dentalcraft, Inc. | 62 |
| Preat | Preat Corporation | 46 |
| MEDENTiKA | Medentika GmbH | 36 |
| Cerec Tessera | Degudent Gmbh | 15 |
| BioHorizons | Biohorizons Implant Systems Inc. | 10 |
| Nobel Biocare N1™ | Nobel Biocare AB | 10 |
| CAD/CAM Software | Sirona Dental Systems Gmbh | 9 |
| Dental Abutment Design Software For Dental Laboratory | Nobel Biocare AB | 7 |
| Cerec | Degudent Gmbh | 6 |
| Preat Implant Prosthetics | Preat Corporation | 4 |
| AbutmentCAD | Exocad Gmbh | 4 |
Showing 12 of 19. All products under Dental Abutment Design Software For Dental Laboratory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181932 | 2019-03-01 |
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.