| Primary Device ID | 07332747124996 |
| NIH Device Record Key | 8533f7c6-fa61-4482-ad6a-5f74f246b666 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 1.2 |
| Catalog Number | 300011 |
| 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 |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747124996 [Primary] |
| LLZ | System, image processing, radiological |
| 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 | 2017-05-30 |
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| 07332747207958 - NobelReplace® | 2025-07-31 NOBELREPLACE® Manual Torque Wrench Adapter Surgical |
| 07332747208085 - NA | 2025-07-31 Screwdriver Manual Ball Abutment 22 mm |
| 07332747208092 - NA | 2025-07-31 Screwdriver Machine Ball Abutment 24 mm |
| 07332747208290 - NA | 2025-07-31 Connection to Handpiece |
| 07332747208306 - NA | 2025-07-31 Impression Coping Open Tray Multi-unit |
| 07332747208313 - Brånemark System® | 2025-07-31 Impression Coping Open Tray Multi-u Brånemark System® WP |