| Primary Device ID | 07290115050370 |
| NIH Device Record Key | 82eb8b4a-2907-4b28-ac8a-48a6d365a7f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | High-Q-Bond Adhesive Resin Cement Automix |
| Version Model Number | 100050AM |
| Company DUNS | 514764117 |
| Company Name | B.J.M. LABORATORIES LTD |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 24 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290115050370 [Primary] |
| EMA | CEMENT, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-30 |
| Device Publish Date | 2023-11-22 |
| 07290115050141 - Multi Bond | 2023-11-30 |
| 07290115050158 - Multi Bond | 2023-11-30 |
| 07290115050370 - High-Q-Bond Adhesive Resin Cement Automix | 2023-11-30 |
| 07290115050370 - High-Q-Bond Adhesive Resin Cement Automix | 2023-11-30 |
| 07290115050448 - Porcelain Fix | 2023-11-30 Single package containing 2 syringes Porcelain Etch and 2 bottles Porcelain Silane |
| 07290115050462 - Porcelain Silane | 2023-11-30 |
| 07290115050479 - Porcelain Etch | 2023-11-30 |
| 07290115052886 - Auto-Cure Activator | 2023-11-30 |