Creative Color® 6031LB

GUDID D7796031LB0

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7796031LB0
• NIH Device Record Key: bb88a905-f67e-496c-a638-8e49b355fc98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creative Color®
• Version Model Number: 6031LB
• Catalog Number: 6031LB
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7796031LB0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854755

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Creative Color®]

• D779603A350: 603A35
• D7796031WO0: 6031WO
• D7796031PO0: 6031PO
• D7796031LB0: 6031LB
• D7796031HY0: 6031HY
• D7796031DB0: 6031DB
• D7796031D30: 6031D3
• D7796031C40: 6031C4
• D7796031C20: 6031C2
• D7796031C10: 6031C1
• D7796031B30: 6031B3
• D7796031B20: 6031B2
• D7796031B00: 6031B0
• D7796031A40: 6031A4
• D7796031A30: 6031A3
• D7796031A20: 6031A2
• D7796031A10: 6031A1
• D7796031140: 603114
• D77960310V0: 60310V
• D77960310G0: 60310G