BRILLIANT EverGlow 60024168

GUDID J00660024168

BRILLIANT EverGlow is a highly filled, radiopaque Universal Submicron Hybrid Composite and is available in universal, translucent and opaque shades. BRILLIANT EverGlow A3/D3, Syringes EcoPack, 5 x 3 g

Coltène/Whaledent AG

Dental composite resin

• Primary Device ID: J00660024168
• NIH Device Record Key: d0fed316-9b26-45e5-ac4a-47c2b1faf74e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRILLIANT EverGlow
• Version Model Number: 60024168
• Catalog Number: 60024168
• 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: true
• 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
• Email: info.ch@coltene.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00660024168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152927

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: 2020-02-14
• Device Publish Date: 2020-02-06

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