DTX Studio™ Lab 300607
GUDID 07332747173314
DTX Studio Lab 1.11 for Windows 64-bit
Nobel Biocare AB
CAD/CAM software| Primary Device ID | 07332747173314 |
| NIH Device Record Key | f0bb8617-8e64-4a77-a17c-25063dd5df23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTX Studio™ Lab |
| Version Model Number | 1.11 |
| Catalog Number | 300607 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747173314 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181932
FDA Product Code
| PNP | Dental abutment design software for dental laboratory |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-02-21 |
| Device Publish Date | 2020-06-17 |
On-Brand Devices [DTX Studio™ Lab]
| 07332747157932 | DTX Studio Lab 1.9 for Windows 64-bit |
| 07332747157949 | DTX Studio Lab 1.10 for Windows 64-bit |
| 07332747180756 | DTX Studio Lab 1.12 for Windows 64-bit |
| 07332747173314 | DTX Studio Lab 1.11 for Windows 64-bit |
Trademark Results [DTX Studio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DTX STUDIO 79205188 5537635 Live/Registered |
Nobel Biocare Services AG 2016-12-22 |
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