BRILLIANT Bulk Fill Flow

GUDID J0006600332800

Coltène/Whaledent AG

Dental composite resin

• Primary Device ID: J0006600332800
• NIH Device Record Key: 94fc6b5c-cfbc-4360-8b38-c6823f596060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRILLIANT Bulk Fill Flow
• Version Model Number: 60033280
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J0006600332800 [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: 2024-09-30
• Device Publish Date: 2024-09-22

On-Brand Devices [BRILLIANT Bulk Fill Flow]

• J0006600368240: 60036824
• J0006600332800: 60033280