COMPONEER 1348
GUDID J00613480
Coltène/Whaledent AG
Dental veneer, professional| Primary Device ID | J00613480 |
| NIH Device Record Key | 72a29f73-d0bd-4d20-85eb-e85c0cb5f325 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COMPONEER |
| Version Model Number | 1348 |
| Catalog Number | 1348 |
| 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 | 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 | +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 | |
| Phone | +41717575300 |
| info.ch@coltene.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 15 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J00613480 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112168
FDA Product Code
| EBF | Material, Tooth Shade, 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 | 2023-07-18 |
| Device Publish Date | 2016-08-15 |
On-Brand Devices [COMPONEER]
| J006C13050 | C1305 |
| J006C13010 | C1301 |
| J00670030 | 7003 |
| J00670020 | 7002 |
| J00670010 | 7001 |
| J00670000 | 7000 |
| J006600145230 | 60014523 |
| J006600145210 | 60014521 |
| J006600145180 | 60014518 |
| J006600145170 | 60014517 |
| J006600145150 | 60014515 |
| J006600145140 | 60014514 |
| J006600145110 | 60014511 |
| J006600145090 | 60014509 |
| J006600145080 | 60014508 |
| J006600145060 | 60014506 |
| J006600145050 | 60014505 |
| J006600145040 | 60014504 |
| J006600143960 | 60014396 |
| J006600143930 | 60014393 |
| J006600143920 | 60014392 |
| J006600142220 | 60014222 |
| J006600140110 | 60014011 |
| J006600140090 | 60014009 |
| J006600140080 | 60014008 |
| J006600140060 | 60014006 |
| J006600140020 | 60014002 |
| J006600139990 | 60013999 |
| J00613800 | 1380 |
| J00613790 | 1379 |
| J00613780 | 1378 |
| J00613740 | 1374 |
| J00613720 | 1372 |
| J00613680 | 1368 |
| J00613660 | 1366 |
| J00613650 | 1365 |
| J00613640 | 1364 |
| J00613600 | 1360 |
| J00613580 | 1358 |
| J00613530 | 1353 |
| J00613490 | 1349 |
| J00613470 | 1347 |
| J00613460 | 1346 |
| J00613430 | 1343 |
| J00613420 | 1342 |
| J00613380 | 1338 |
| J00613350 | 1335 |
| J00613330 | 1333 |
| J00613300 | 1330 |
| J00613280 | 1328 |
Trademark Results [COMPONEER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMPONEER 79094682 4188453 Live/Registered |
Coltène/Whaledent AG 2011-02-03 |
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