| Primary Device ID | 07332747015096 |
| NIH Device Record Key | 65d888d3-707c-4d83-ac65-9eff65a29dcf |
| Commercial Distribution Discontinuation | 2018-03-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | DCA 225-0 |
| Catalog Number | DCA 225-0 |
| 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 | true |
| 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 | 07332747015096 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-09-17 |
| 07332747207712 - Nobel Biocare® | 2025-07-31 Direct Abutment Engaging Plastic 3.8/4.5 HL |
| 07332747207736 - Nobel Biocare® | 2025-07-31 Direct Abutment Engaging Plastic 3.25 HL |
| 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 |