| Primary Device ID | 07290119312306 |
| NIH Device Record Key | aad5bac6-6302-43ef-b6c6-3ef46bcd36db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FG Dental Burs |
| Version Model Number | 878K/012 |
| Catalog Number | BIO-298/012 |
| 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 | 07290119312306 [Primary] |
| DZP | Instrument, Diamond, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
[07290119312306]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-18 |
| Device Publish Date | 2025-03-10 |