AFFINIS PRECIOUS 3850
GUDID J00638500
Coltène/Whaledent AG
Silicone dental impression material| Primary Device ID | J00638500 |
| NIH Device Record Key | e3c5962d-3e17-4fa5-b24f-b9ec1560b578 |
| Commercial Distribution Discontinuation | 2021-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AFFINIS PRECIOUS |
| Version Model Number | 3850 |
| Catalog Number | 3850 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J00638500 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K912485
FDA Product Code
| ELW | Material, Impression |
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 | 2016-08-15 |
On-Brand Devices [AFFINIS PRECIOUS]
| J00667800 | 6780 |
| J00667790 | 6779 |
| J006600191670 | 60019167 |
| J00638650 | 3865 |
| J00638500 | 3850 |
| J00637990 | 3799 |
| J00637560 | 3756 |
| 07640181479993 | 3851 |
| 07640181479375 | 6776 |
| 07640181479368 | 6775 |
Trademark Results [AFFINIS PRECIOUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFINIS PRECIOUS 79027286 3265372 Live/Registered |
Coltène/Whaledent AG 2006-06-29 |
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