| Primary Device ID | 20810111541873 |
| NIH Device Record Key | 61f55948-5b67-4afb-84b9-1e49e3f21127 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aelite LS Posterior |
| Version Model Number | H-722A3 |
| Catalog Number | H-722A3 |
| Company DUNS | 053529939 |
| Company Name | BISCO INC. |
| Device Count | 15 |
| 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 | 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 |
| 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 |
|---|---|
| GS1 | 00810111541879 [Unit of Use] |
| GS1 | 10810111541876 [Primary] |
| GS1 | 20810111541873 [Package] Contains: 10810111541876 Package: Item No: H-722A3P [1 Units] In Commercial Distribution |
| HIBCC | D757H722A30 [Previous] |
| 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 | 2022-11-25 |
| Device Publish Date | 2022-11-17 |
| D757H722B1P1 | Aelite LS Posterior B1 15ct Unit Dose (0.25g ea) Pkg |
| D757H722A3P1 | Aelite LS Posterior A3 15ct Unit Dose (0.25g ea) Pkg |
| D757H722A35P1 | Aelite LS Posterior A3.5 15ct Unit Dose (0.25g ea) Pkg |
| D757H722A30 | Aelite LS Posterior A3 15ct Unit Dose (0.25g ea) |
| D757H722A2P1 | Aelite LS Posterior A2 15ct Unit Dose (0.25g ea) Pkg |
| D757H722A1P1 | Aelite LS Posterior A1 15ct Unit Dose (0.25g ea) |
| D757H721B1P1 | Aelite LS Posterior B1 4g Syringe Pkg |
| D757H721B10 | Aelite LS Posterior B1 4g Syringe |
| D757H721A3P1 | Aelite LS Posterior A3 4g Syringe Pkg |
| D757H721A35P1 | Aelite LS Posterior A3.5 4g Syringe Pkg |
| D757H721A350 | Aelite LS Posterior A3.5 4g Syringe |
| D757H721A30 | Aelite LS Posterior A3 4g Syringe |
| D757H721A2P1 | Aelite LS Posterior A2 4g Syringe Pkg |
| D757H721A20 | Aelite LS Posterior A2 4g Syringe |
| D757H721A1P1 | Aelite LS Posterior A1 4g Syringe Pkg |
| D757H721A10 | Aelite LS Posterior A1 4g Syringe |
| D757H722B10 | Aelite LS Posterior B1 15ct Unit Dose (0.25g ea) |
| D757H722A350 | Aelite LS Posterior A3.5 15ct Unit Dose (0.25g ea) |
| D757H722A20 | Aelite LS Posterior A2 15ct Unit Dose (0.25g ea) |
| D757H722A10 | Aelite LS Posterior A1 15ct Unit Dose (0.25g ea) |
| 10810111541807 | Aelite LS Posterior A1 4g Syringe |
| 10810111541814 | Aelite LS Posterior A2 4g Syringe |
| 20810111541866 | Aelite LS Posterior A2 15ct Unit Dose (0.25g ea) |
| 10810111541845 | Aelite LS Posterior B1 4g Syringe |
| 10810111541838 | Aelite LS Posterior A3.5 4g Syringe |
| 10810111541821 | Aelite LS Posterior A3 4g Syringe |
| 20810111541873 | Aelite LS Posterior A3 15ct Unit Dose (0.25g ea) |