| Primary Device ID | 20810111541637 |
| NIH Device Record Key | dc17172a-ab4f-4311-b3c8-92ddf7e01cfe |
| Commercial Distribution Discontinuation | 2025-04-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Aelite Aesthetic Enamel |
| Version Model Number | H-854B3 |
| Catalog Number | H-854B3 |
| 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 |
| 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 |
| D757H854W2P1 | Aelite Aesthetic Enamel Bleach W-E 15ct Unit Dose (0.25g ea) Pkg |
| D757H854W20 | Aelite Aesthetic Enamel Bleach W-E 15ct Unit Dose (0.25g ea) |
| D757H854FRP1 | Aelite Aesthetic Enamel Incisal Frost 15ct Unit Dose (0.25g ea) Pkg |
| D757H854FR0 | Aelite Aesthetic Enamel Incisal Frost 15ct Unit Dose (0.25g ea) |
| D757H854D4P1 | Aelite Aesthetic Enamel D4 15ct Unit Dose (0.25g ea) Pkg |
| D757H854D40 | Aelite Aesthetic Enamel D4 15ct Unit Dose (0.25g ea) |
| D757H854D2P1 | Aelite Aesthetic Enamel D2 15ct Unit Dose (0.25g ea) Pkg |
| D757H854D20 | Aelite Aesthetic Enamel D2 15ct Unit Dose (0.25g ea) |
| D757H854CLP1 | Aelite Aesthetic Enamel Incisal Clear 15ct Unit Dose (0.25g ea) Pkg |
| D757H854CL0 | Aelite Aesthetic Enamel Incisal Clear 15ct Unit Dose (0.25g ea) |
| D757H854B4P1 | Aelite Aesthetic Enamel B4 15ct Unit Dose (0.25g ea) Pkg |
| D757H854B40 | Aelite Aesthetic Enamel B4 15ct Unit Dose (0.25g ea) |
| D757H854B3P1 | Aelite Aesthetic Enamel B3 15ct Unit Dose (0.25g ea) Pkg |
| D757H854B30 | Aelite Aesthetic Enamel B3 15ct Unit Dose (0.25g ea) |
| D757H854B2P1 | Aelite Aesthetic Enamel B2 15ct Unit Dose (0.25g ea) Pkg |
| D757H854B20 | Aelite Aesthetic Enamel B2 15ct Unit Dose (0.25g ea) |
| D757H854B1P1 | Aelite Aesthetic Enamel B1 15ct Unit Dose (0.25g ea) Pkg |
| D757H854B10 | Aelite Aesthetic Enamel B1 15ct Unit Dose (0.25g ea) |
| D757H854A4P1 | Aelite Aesthetic Enamel A4 15ct Unit Dose (0.25g ea) Pkg |
| D757H854A40 | Aelite Aesthetic Enamel A4 15ct Unit Dose (0.25g ea) |
| D757H854A3P1 | Aelite Aesthetic Enamel A3 15ct Unit Dose (0.25g ea) Pkg |
| D757H854A35P1 | Aelite Aesthetic Enamel A3.5 15ct Unit Dose (0.25g ea) Pkg |
| D757H854A350 | Aelite Aesthetic Enamel A3.5 15ct Unit Dose (0.25g ea) |
| D757H854A30 | Aelite Aesthetic Enamel A3 15ct Unit Dose (0.25g ea) |
| D757H854A2P1 | Aelite Aesthetic Enamel A2 15ct Unit Dose (0.25g ea) Pkg |
| D757H854A20 | Aelite Aesthetic Enamel A2 15ct Unit Dose (0.25g ea) |
| D757H854A1P1 | Aelite Aesthetic Enamel A1 15ct Unit Dose (0.25g ea) Pkg |
| D757H854A10 | Aelite Aesthetic Enamel A1 15ct Unit Dose (0.25g ea) |
| D757H852W2P1 | Aelite Aesthetic Enamel Bleach W-E Syringe Pkg |
| D757H852W20 | Aelite Aesthetic Enamel Bleach W-E Syringe |
| D757H852FRP1 | Aelite Aesthetic Enamel Incisal Frost Syringe Pkg |
| D757H852FR0 | Aelite Aesthetic Enamel Incisal Frost Syringe |
| D757H852D4P1 | Aelite Aesthetic Enamel D4 Syringe Pkg |
| D757H852D40 | Aelite Aesthetic Enamel D4 Syringe |
| D757H852D2P1 | Aelite Aesthetic Enamel D2 Syringe Pkg |
| D757H852D20 | Aelite Aesthetic Enamel D2 Syringe |
| D757H852CLP1 | Aelite Aesthetic Enamel Incisal Clear Syringe Pkg |
| D757H852CL0 | Aelite Aesthetic Enamel Incisal Clear Syringe |
| D757H852B4P1 | Aelite Aesthetic Enamel B4 Syringe Pkg |
| D757H852B40 | Aelite Aesthetic Enamel B4 Syringe |
| D757H852B3P1 | Aelite Aesthetic Enamel B3 Syringe Pkg |
| D757H852B30 | Aelite Aesthetic Enamel B3 Syringe |
| D757H852B2P1 | Aelite Aesthetic Enamel B2 Syringe Pkg |
| D757H852B20 | Aelite Aesthetic Enamel B2 Syringe |
| D757H852B1P1 | Aelite Aesthetic Enamel B1 Syringe Pkg |
| D757H852B10 | Aelite Aesthetic Enamel B1 Syringe |
| D757H852A4P1 | Aelite Aesthetic Enamel A4 Syringe Pkg |
| D757H852A40 | Aelite Aesthetic Enamel A4 Syringe |
| D757H852A3P1 | Aelite Aesthetic Enamel A3 Syringe Pkg |
| D757H852A35P1 | Aelite Aesthetic Enamel A3.5 Syringe Pkg |