AFFINIS PRECIOUS 60019167
GUDID J006600191670
Coltène/Whaledent AG
Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material| Primary Device ID | J006600191670 |
| NIH Device Record Key | 21727aca-8956-43f1-ba61-b4652c53ff58 |
| Commercial Distribution Discontinuation | 2021-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AFFINIS PRECIOUS |
| Version Model Number | 60019167 |
| Catalog Number | 60019167 |
| 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
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J006600191670 [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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