| Primary Device ID | 00359883000615 |
| NIH Device Record Key | 5cad0f5c-7010-4b9d-ab27-a2043d973b21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowerMix™ Dynamic Mixing Tips |
| Version Model Number | 033539 |
| Catalog Number | 033539 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Outer Diameter | 7.8 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00359883000615 [Primary] |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-20 |
| Device Publish Date | 2025-03-12 |
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| 00359883000615 - PowerMix™ Dynamic Mixing Tips | 2025-03-20Dental material mixing nozzle, non-sterile |
| 00359883000615 - PowerMix™ Dynamic Mixing Tips | 2025-03-20 Dental material mixing nozzle, non-sterile |