| 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 |
| 07332747225433 - NobelProcera® | 2025-05-16 Nobel Dummy Material 2 FDA Integration |
| 07332747207811 - NA | 2025-05-02 Implant Analog 3.8/4.5 HL |
| 07332747221183 - DTX Studio™ Clinic | 2025-05-02 DTX Studio Clinic 4.5 for Win 64-bit |
| 07332747221190 - DTX Studio™ Clinic | 2025-05-02 DTX Studio Clinic 4.5 for Mac |
| 07332747225426 - NA | 2025-05-02 Nobel Dummy Material for FDA Integration |
| 07332747150377 - Nobel Biocare® | 2025-04-30 Coping Screw Hex 2mm 4/pkg |
| 07332747207842 - Nobel Biocare® | 2025-04-03 Direct Abutment Engaging Gold/Plastic 5.0 HL/RPL |
| 07332747207859 - Nobel Biocare® | 2025-04-03 Direct Abutment Non-Engaging Gold/Plastic 5.0 HL/RPL |