| Primary Device ID | 07332747149487 |
| NIH Device Record Key | 3f2ded32-d81f-45f4-8387-6430ce627e0d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTX Studio design |
| Version Model Number | 300160_V1.7_WIN64 |
| Catalog Number | 300160_V1.7_WIN64 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747149487 [Primary] |
| NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2018-02-02 |
| 07332747224665 - NA | 2025-05-27 Temporary Prosthetic Screw Multi-unit Abutment |
| 07332747207828 - Nobel Biocare® | 2025-05-26 Abutment Screw TorqTite 3.8/4.3/4.5/5.0/6.0 HL/RPL |
| 07332747207835 - NA | 2025-05-26 Implant Analog 5.0 HL/RPL |
| 07332747207880 - NA | 2025-05-26 Implant Analog 6.0 HL/RPL |
| 07332747150384 - Nobel Biocare® | 2025-05-26 Prosthetic screw UniGrip™ Novum 2-pack |
| 07332747150391 - Nobel Biocare® | 2025-05-26 Lower bar screw UniGrip™ Novum 3-pack |
| 07332747207910 - NA | 2025-05-26 Replica Fixture Novum |
| 07332747207927 - Brånemark System® | 2025-05-26 Screw Ceramic Abutment Bmk Syst RP |