TENURE 039811401
GUDID D8130398114010
TENURE MPB SYSTEM BAG
DEN-MAT HOLDINGS, LLC
Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set| Primary Device ID | D8130398114010 |
| NIH Device Record Key | 06b621cb-c5f6-475d-85b3-7f2c65c34760 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TENURE |
| Version Model Number | 039811401 |
| Catalog Number | 039811401 |
| 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 | true |
| 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 | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com | |
| Phone | 1-800433-6628 |
| info@denmat.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
| Handling Environment Humidity | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 47 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to temperature exceeding 80 degrees F 27 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct light |
| Special Storage Condition, Specify | Between 0 and 0 *Recommended temperature when used is 70-75 degrees F (21 - 24 degrees C) |
| Special Storage Condition, Specify | Between 0 and 0 *Cold storage recommended in tropical climates |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130398114010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K872510
FDA Product Code
| KLE | Agent, Tooth Bonding, Resin |
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 | 2024-05-16 |
| Device Publish Date | 2024-05-08 |
On-Brand Devices [TENURE]
| D8130398140000 | TENURE 4G SAMPLE PACK |
| D8130398114010 | TENURE MPB SYSTEM BAG |
Trademark Results [TENURE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENURE 97638608 not registered Live/Pending |
Hand in Hand Health, Inc. 2022-10-19 |
 TENURE 97148219 not registered Live/Pending |
Gowan Company, L.L.C. 2021-11-30 |
 TENURE 87907455 not registered Live/Pending |
ISAGRO S.p.A. 2018-05-04 |
 TENURE 87812077 not registered Dead/Abandoned |
DRVIN, LLC 2018-02-27 |
 TENURE 77348959 3573709 Live/Registered |
SAZERAC BRANDS, LLC 2007-12-11 |
 TENURE 76408988 not registered Dead/Abandoned |
Dow AgroSciences LLC 2002-05-16 |
 TENURE 75465225 not registered Dead/Abandoned |
Dow AgroSciences LLC 1998-04-09 |
 TENURE 74327463 1781055 Live/Registered |
DEN-MAT HOLDINGS, LLC 1992-10-30 |
 TENURE 74068753 1767868 Dead/Cancelled |
DowElanco 1990-06-13 |
 TENURE 73436316 1288623 Dead/Cancelled |
DOW CHEMICAL COMPANY, THE 1983-07-25 |
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