BRILLIANT EverGlow Flow 60019760

GUDID J00660019760

BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in several shades. BRILLIANT EverGlow Flow Intro Kit including universal Colors A1/B1, A2/B2, A3.5/B2, A3/D3

Coltène/Whaledent AG

Dental composite resin

• Primary Device ID: J00660019760
• NIH Device Record Key: ca5e714a-df9e-432c-9d85-b5ee717bf7d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRILLIANT EverGlow Flow
• Version Model Number: 60019760
• Catalog Number: 60019760
• 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: 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage: 4-23 °C / 39-73 °F.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00660019760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190597

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: 2019-07-08
• Device Publish Date: 2019-06-28

On-Brand Devices [BRILLIANT EverGlow Flow]

• J00660019760: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
• J00660019758: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
• J00660019757: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
• J00660019756: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
• J00660019755: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
• J00660019754: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
• J00660019753: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev
• J00660019752: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid composite and available in sev
• J00660019751: BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid Composite and available in sev