| Primary Device ID | 07332747013955 |
| NIH Device Record Key | eaf97352-1d8d-4456-a240-d9313330b549 |
| Commercial Distribution Discontinuation | 2018-03-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | 34145 |
| Catalog Number | 34145 |
| 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 |
| Phone | +1(800)322-5001 |
| us.customerservice@nobelbiocare.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747013955 [Primary] |
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2015-09-17 |
| 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 |
| 07332747207866 - Nobel Biocare® | 2025-04-03 Direct Abutment Engaging Gold/Plastic 6.0 HL/RPL |
| 07332747207873 - Nobel Biocare® | 2025-04-03 Direct Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL |
| 07332747208108 - Nobel Biocare® | 2025-04-03 Temporary Abutment Engaging Brånemark System® NP |
| 07332747208115 - Nobel Biocare® | 2025-04-03 Temporary Abutment Non-Engaging Bmk Syst NP |
| 07332747208122 - Nobel Biocare® | 2025-04-03 Temporary Abutment Engaging Brånemark System® RP |
| 07332747208139 - Nobel Biocare® | 2025-04-03 Temporary Abutment Non-Engaging Bmk Syst RP |