| Primary Device ID | 07290119310029 |
| NIH Device Record Key | 78ba1485-808f-4209-aa8d-3dd3e28dcf6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drill Extension |
| Version Model Number | 4.5mm Diameter x 28mm Length |
| Catalog Number | BIO-D3412 |
| Company DUNS | 532209134 |
| Company Name | BIOLINE DENTAL IMPLANT SYSTEMS LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290119310029 [Primary] |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
[07290119310029]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-21 |
| Device Publish Date | 2025-03-13 |
| 07290119310609 - Driver Hex 1.25mm | 2025-03-31 |
| 07290119310616 - Driver Hex 1.25mm | 2025-03-31 |
| 07290119310623 - Driver Hex 1.25mm | 2025-03-31 |
| 07290119310630 - Driver Hex 2.42mm | 2025-03-31 |
| 07290119310647 - Driver Hex 2.42mm | 2025-03-31 |
| 07290119310654 - Driver Hex 2.42mm | 2025-03-31 |
| 07290119310661 - Slim Hex Driver 2.1mm | 2025-03-31 |
| 07290119310678 - Slim Hex Driver 2.1mm | 2025-03-31 |