| Primary Device ID | 07332747002799 |
| NIH Device Record Key | 439409ce-c266-4dc3-8c02-a5e09e524a65 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 33455 |
| Catalog Number | 33455 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Outer Diameter | 7 Millimeter |
| Height | 3 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747002799 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| NHA | Abutment, implant, dental, endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| 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 |