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
| 03598833235166 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE ENW SYR |
| 03598833235265 - EVANESCE | 2025-01-07 EVANESCE EVANESCE INJECTABLE |
| 03598833235272 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE A2U SYR |
| 03598833235289 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE B1U SYR |
| 03598833235296 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE BL1U SYR |
| 03598833235302 - EVANESCE | 2025-01-07 EVANESCE INJECTABLE A3U SYR |
| 00359883973216 - EVANESCE | 2024-12-23 EVANESCE BULK CURE A2 SY 1x3g |
| 03598833215236 - EVANESCE | 2024-12-23 EVANESCE BULK FILL A2 SY 1X6G |
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 |
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