| Primary Device ID | D757MXWL0080 |
| NIH Device Record Key | e2a5c609-f7d0-4cce-838d-454d2db63a73 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disp. Mixing Well, #A-868 |
| Version Model Number | MXWL-008 |
| Catalog Number | MXWL-008 |
| Company DUNS | 053529939 |
| Company Name | BISCO INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D757MXWL0080 [Primary] |
| KXR | APPLICATOR, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-04 |
| Device Publish Date | 2018-11-12 |
| 00810111543323 - Quantium | 2025-08-06 Quantium A2 Body 1g Syringe |
| 00810111543330 - Quantium | 2025-08-06 Quantium A2 Enamel 1g Syringe |
| 00810111543347 - Quantium | 2025-08-06 Quantium A2 Body & A2 Enamel Syringe (1g each) Sample Package |
| 10810111541500 - Aelite Aesthetic Enamel | 2025-07-30 Aelite Aesthetic Enamel B4 Syringe |
| 10810111541548 - Aelite Aesthetic Enamel | 2025-07-30 Aelite Aesthetic Enamel Incisal Frost Syringe |
| 10810111542255 - eCement | 2025-07-30 eCement LC A1 4.5g Syringe |
| 20810111541606 - Aelite Aesthetic Enamel | 2025-07-30 Aelite Aesthetic Enamel A4 15ct Unit Dose (0.25g ea) |
| 20810111541637 - Aelite Aesthetic Enamel | 2025-07-30 Aelite Aesthetic Enamel B3 15ct Unit Dose (0.25g ea) |