BRILLIANT EverGlow 60019728
GUDID J006600197280
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 | J006600197280 |
| NIH Device Record Key | 6f3184dc-d25f-4c69-8276-2fcdc59b68f9 |
| Commercial Distribution Discontinuation | 2021-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BRILLIANT EverGlow |
| Version Model Number | 60019728 |
| Catalog Number | 60019728 |
| 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 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 | J006600197280 [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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