Dab-Eze® 031145201B
GUDID D813031145201B0
DAB-EZE TENURE S 3g
DEN-MAT HOLDINGS, LLC
Dentine bonding agent/set| Primary Device ID | D813031145201B0 |
| NIH Device Record Key | b15f10df-696b-4e70-b380-eaaa97bfc1f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dab-Eze® |
| Version Model Number | 031145201B |
| Catalog Number | 031145201B |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 1 |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813031145201B0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K801216
FDA Product Code
| KLE | Agent, Tooth Bonding, Resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by DEN-MAT HOLDINGS, LLC
| 00359883007201 - EVANESCE | 2025-06-09 19g MIXING TIPS 25pk |
| 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 |
Trademark Results [Dab-Eze]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DAB-EZE 74194234 1701618 Dead/Cancelled |
DEN-MAT HOLDINGS, LLC 1991-08-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.