Acu-Flow™ Heavy Body 6-Pack 1-016402
GUDID 00359883003289
Hydrophillic Impression Material
DEN-MAT HOLDINGS, LLC
Silicone dental impression material| Primary Device ID | 00359883003289 |
| NIH Device Record Key | 3d2492cc-57f9-4c0a-abd3-2b27a7be72c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acu-Flow™ Heavy Body 6-Pack |
| Version Model Number | 1-016402 |
| Catalog Number | 1-016402 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 6 |
| 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 | false |
| 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 |
Customer Support Contacts
| 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 |
Device Dimensions
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
| Total Volume | 300 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Storage Environment Temperature | Between 17 Degrees Celsius and 24 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00359883003289 [Unit of Use] |
| GS1 | 00359883003296 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K053018
FDA Product Code
| ELW | MATERIAL, IMPRESSION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-20 |
| Device Publish Date | 2025-03-12 |
Devices Manufactured by DEN-MAT HOLDINGS, LLC
| 00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack | 2025-03-26 Gingival Retraction Solution |
| 00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit | 2025-03-26 Gingival Retraction Solution |
| 00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack | 2025-03-24 VPS Impression Material |
| 00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack | 2025-03-21 Wheel, Polishing Agent |
| 00359883006501 - Clinician's Choice® G5 Sample Pack | 2025-03-21 Dental coating, tooth-desensitizing, professional |
| 00359883000608 - PowerMix™ Automatic Impression Material Dispenser | 2025-03-20 Two-component dental material applicator, electric |
| 00359883000615 - PowerMix™ Dynamic Mixing Tips | 2025-03-20 Dental material mixing nozzle, non-sterile |
| 00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange | 2025-03-20 Device to engage the matrices and separate teeth |
Trademark Results [Acu-Flow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACU-FLOW 90332507 not registered Live/Pending |
CLINICIAN'S CHOICE DENTAL PRODUCTS INC. 2020-11-20 |
 ACU-FLOW 86725536 5172287 Live/Registered |
SPA WORLD CORPORATION 2015-08-14 |
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