| Primary Device ID | D757A1725P1 |
| NIH Device Record Key | 2320d919-fb25-45e1-bb8d-65c34d1c6980 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Light-Core |
| Version Model Number | A-1725P |
| Catalog Number | A-1725P |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| 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 | D757A1725P1 [Primary] |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-05-19 |
| Device Publish Date | 2017-06-12 |
| D757A1729P1 | Light-Core Blue Unit Dose 10ct Pkg |
| D757A1728P1 | Light-Core Blue 2-5g Syr Pkg |
| D757A1727P1 | Light-Core Translucent 2-5g Syr Pkg |
| D757A17270 | Light-Core Translucent 5g Syringe |
| D757A1725P1 | Light-Core Translucent Unit Dose 10ct Pkg |
| D757A17150B1 | Light-Core Blue 150 U/D Tips Pkg |
| D757A17280 | Light-Core Blue 5g Syringe |
| 10810111540893 | Light-Core Translucent 2-5g Syr Pkg |
| 00810111540896 | Light-Core Translucent 5g Syringe |
| 00810111540926 | Light-Core Blue 150 U/D Tips Pkg |
| 10810111540909 | Light-Core Blue 5g Syringe |
| 00810111540919 | Light-Core Translucent Unit Dose 10ct Pkg |