| Primary Device ID | 07332747166651 |
| NIH Device Record Key | f58c7537-5b7d-4e15-891b-c002b6a73d71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTX Studio™ Core |
| Version Model Number | 3.7 |
| Catalog Number | 300547 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747166651 [Primary] |
| OUG | Medical device data system |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2019-05-07 |
| 07332747166651 | DTX Studio Core 3.7 for Windows 64-bit |
| 07332747172874 | DTX Studio Core 3.8 for Windows 64-bit |
| 07332747180817 | DTX Studio Core 3.9 for Windows 64-bit |
| 07332747185102 | DTX Studio Core 3.10 for Windows 64-bit |
| 07332747187090 | DTX Studio Core 3.11 for Windows 64-bit |
| 07332747197136 | DTX Studio Core 3.13 for Windows 64-bit |
| 07332747197129 | DTX Studio Core 3.12 for Windows 64-bit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DTX STUDIO 79205188 5537635 Live/Registered |
Nobel Biocare Services AG 2016-12-22 |