DuoCem 60014381
GUDID J006600143810
Coltène/Whaledent AG
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin| Primary Device ID | J006600143810 |
| NIH Device Record Key | 375ba01d-2322-471c-9ee8-ac2faf39325b |
| Commercial Distribution Discontinuation | 2021-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DuoCem |
| Version Model Number | 60014381 |
| Catalog Number | 60014381 |
| Company DUNS | 480017482 |
| Company Name | Coltène/Whaledent AG |
| 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 | true |
| 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 | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com | |
| Phone | +41717575300 |
| info.ch@coltene.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J006600143810 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160800
FDA Product Code
| EMA | Cement, Dental |
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 | 2021-11-22 |
| Device Publish Date | 2017-01-11 |
On-Brand Devices [DuoCem]
| J006600195640 | 60019564 |
| J006600195630 | 60019563 |
| J006600143910 | 60014391 |
| J006600143810 | 60014381 |
Trademark Results [DuoCem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUOCEM 79116331 4322685 Live/Registered |
Coltène/Whaledent AG 2012-07-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.