BRILLIANT EverGlow

GUDID 07640181476947

Univ. Comp B-EA1

Coltène/Whaledent AG

Dental composite resin

• Primary Device ID: 07640181476947
• NIH Device Record Key: d0bf292e-62cb-4a3a-b7c3-6489310bb191
• Commercial Distribution Discontinuation: 2026-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRILLIANT EverGlow
• Version Model Number: Univ. Comp B-EA1
• 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
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640181476947 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-16
• Device Publish Date: 2025-07-08

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
• 07640181476985: Univ. Comp B-EB1
• 07640181476961: Univ. Comp B-EA3
• 07640181476954: Univ. Comp B-EA2
• 07640181476947: Univ. Comp B-EA1