OFA Coloring Liquid CL-OFA-KIT

GUDID D791CLOFAKIT0

TALLADIUM, INC.

Dental prosthesis dye

• Primary Device ID: D791CLOFAKIT0
• NIH Device Record Key: 6f26418b-8678-4728-8cad-c0f3a95b989b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OFA Coloring Liquid
• Version Model Number: CL-OFA-KIT
• Catalog Number: CL-OFA-KIT
• Company DUNS: 094430642
• Company Name: TALLADIUM, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D791CLOFAKIT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143090

FDA Product Code

• EIH: Powder, Porcelain

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: 2019-03-11
• Device Publish Date: 2019-02-20

On-Brand Devices [OFA Coloring Liquid]

• D791CLOFAKIT0: CL-OFA-KIT
• D791CLOFAA10: CL-OFA-A1