BRILLIANT EverGlow 60019725
GUDID J006600197250
Coltène/Whaledent AG
Dental composite resin| Primary Device ID | J006600197250 |
| NIH Device Record Key | cdbb0da9-bc96-4bae-add2-1c5b7f66e7f2 |
| Commercial Distribution Discontinuation | 2021-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BRILLIANT EverGlow |
| Version Model Number | 60019725 |
| Catalog Number | 60019725 |
| 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 | 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 | +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 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 Degrees Celsius and 23 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP AWAY FROM SUNLIGHT |
| Storage Environment Temperature | Between 4 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 | J006600197250 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152927
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 | 2021-11-22 |
| Device Publish Date | 2016-09-01 |
On-Brand Devices [BRILLIANT EverGlow]
| J00660024169 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J00660024168 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J00660024167 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J00660024166 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J00660024163 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J00660024162 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J00660024161 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J00660024160 | BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is av |
| J006600219200 | 60021920 |
| J006600197370 | 60019737 |
| J006600197360 | 60019736 |
| J006600197350 | 60019735 |
| J006600197290 | 60019729 |
| J006600197280 | 60019728 |
| J006600197250 | 60019725 |
| J006600197240 | 60019724 |
Trademark Results [BRILLIANT EverGlow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRILLIANT EVERGLOW 79171038 4894038 Live/Registered |
Coltène/Whaledent AG 2015-06-25 |
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