| Primary Device ID | D757H672B10 |
| NIH Device Record Key | b9fac090-2725-4ddb-9397-cba79d2b4549 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aeliteflo |
| Version Model Number | H-672B1 |
| Catalog Number | H-672B1 |
| Company DUNS | 053529939 |
| Company Name | BISCO INC. |
| 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 | 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(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D757H672B10 [Primary] |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-25 |
| Device Publish Date | 2022-05-17 |
| D757H675TIF1 | AELITEFLO Composite Tran. Syr. |
| D757H675TI0 | AELITEFLO L/C Comp Tr 1.5gm |
| D757H675OWF1 | AELITEFLO Composite W-Op. Syr. |
| D757H675OW0 | AELITEFLO L/C Comp W-O 1.5gm |
| D757H674D3F1 | AELITEFLO Composite D3 Syr. |
| D757H674D30 | AELITEFLO L/C Comp D3 1.5gm |
| D757H673C3F1 | AELITEFLO Composite C3 Syr. |
| D757H673C30 | AELITEFLO L/C Comp C3 1.5gm |
| D757H673C2F1 | AELITEFLO Composite C2 Syr. |
| D757H673C20 | AELITEFLO L/C Comp C2 1.5gm |
| D757H672B1F1 | AELITEFLO Composite B1 Syr. |
| D757H671A5F1 | AELITEFLO Composite A5 Syr. |
| D757H671A50 | AELITEFLO L/C Comp A5 1.5gm |
| D757H671A3F1 | AELITEFLO Composite A3 Syr. |
| D757H671A35F1 | AELITEFLO Composite A3.5 Syr. |
| D757H671A350 | AELITEFLO L/C Comp A3.5 1.5gm |
| D757H671A30 | AELITEFLO L/C Comp A3 1.5gm |
| D757H671A2OF1 | AELITEFLO Composite A2O Syr. |
| D757H671A2O0 | AELITEFLO Composite A2O 1.5gm |
| D757H671A2F1 | AELITEFLO Composite A2 Syr. |
| D757H671A20 | AELITEFLO L/C Comp A2 1.5gm |
| D757H671A1F1 | AELITEFLO Composite A1 Syr. |
| D757H671A10 | AELITEFLO L/C Comp A1 1.5gm |
| D757H672B10 | AELITEFLO L/C Comp B1 1.5gm |
| 00810111540209 | AELITEFLO Composite A3 Syr. |
| 00810111540193 | AELITEFLO L/C Comp A3 1.5gm |
| 00810111540162 | AELITEFLO Composite A2 Syr. |
| 00810111540155 | AELITEFLO L/C Comp A2 1.5gm |
| 00810111540148 | AELITEFLO Composite A1 Syr. |
| 00810111540346 | AELITEFLO Composite White Opaque. Syr. Package |
| 00810111540278 | AELITEFLO L/C Comp C2 1.5gm |
| 00810111540360 | AELITEFLO Composite Tran. Syr. |
| 00810111540285 | AELITEFLO Composite C2 Syr. Pkg |
| 00810111540254 | AELITEFLO L/C Comp B1 1.5gm |
| 00810111540223 | AELITEFLO Composite A3.5 Syr. Pkg |
| 00810111540216 | AELITEFLO L/C Comp A3.5 1.5gm |
| 00810111540131 | AELITEFLO L/C Comp A1 1.5gm |
| 00810111540353 | AELITEFLO L/C Comp Tr 1.5gm |
| 00810111540261 | AELITEFLO Composite B1 Syr. |
| 00810111540179 | AELITEFLO Composite A2O 1.5gm |
| 00810111540186 | AELITEFLO Composite A2O Syr. |
| 00810111540339 | AELITEFLO L/C Composite Opaque White 1.5gm |
| 00810111540322 | AELITEFLO Composite D3 Syr. |