DTX Studio™ AI SDK 301913
GUDID 07332747207422
DTX Studio AI SDK 1.0 for Windows 64-bit
Nobel Biocare AB
Radiology DICOM image processing application software| Primary Device ID | 07332747207422 |
| NIH Device Record Key | 92b7fbc2-d0e3-42f1-844a-b1e2790a0b91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTX Studio™ AI SDK |
| Version Model Number | 1 |
| Catalog Number | 301913 |
| 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 | true |
| 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 | 07332747207422 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221921
FDA Product Code
| MYN | Analyzer, medical image |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-06 |
| Device Publish Date | 2023-09-28 |
Devices Manufactured by Nobel Biocare AB
| 07332747220445 - Unigrip™ Plus | 2025-12-29 Screwdriver Manual Unigrip Plus 20 mm |
| 07332747220452 - Unigrip™ Plus | 2025-12-29 Screwdriver Manual Unigrip Plus 28 mm |
| 07332747220469 - Unigrip™ Plus | 2025-12-29 Screwdriver Manual Unigrip Plus 36 mm |
| 07332747220476 - Unigrip™ Plus | 2025-12-29 Screwdriver Machine Unigrip Plus 20 mm |
| 07332747220483 - Unigrip™ Plus | 2025-12-29 Screwdriver Machine Unigrip Plus 25 mm |
| 07332747220490 - Unigrip™ Plus | 2025-12-29 Screwdriver Machine Unigrip Plus 30 mm |
| 07332747220506 - Unigrip™ Plus | 2025-12-29 Screwdriver Machine Unigrip Plus 35 mm |
| 07332747221855 - DTX Studio™ Assist | 2025-12-09 DTX Studio Assist 1.1 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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