DTX Studio™ design 300160
GUDID 07332747126464
DTX Studio design 1.5 for Windows 64-bit
Nobel Biocare AB
Dental CAD/CAM system, laboratory| Primary Device ID | 07332747126464 |
| NIH Device Record Key | c1c74e14-f8cc-47a2-9229-973536fec274 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTX Studio™ design |
| Version Model Number | 1.5 |
| Catalog Number | 300160 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 07332747126464 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171466
FDA Product Code
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2018-02-07 |
On-Brand Devices [DTX Studio™ design]
| 07332747155358 | DTX Studio design 1.8 for Windows 64-bit |
| 07332747126464 | DTX Studio design 1.5 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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