Tilite Ceramic Alloys - Omega

GUDID D7911110

TALLADIUM, INC.

Dental casting non-noble alloy

• Primary Device ID: D7911110
• NIH Device Record Key: 422f4ed8-44aa-4b43-94f9-f7da46f78635
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tilite Ceramic Alloys - Omega
• Version Model Number: 111
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	D7911110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894085

FDA Product Code

• EJH: Alloy, Metal, Base

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: 2016-10-24

On-Brand Devices [Tilite Ceramic Alloys - Omega]

• D7911110: 111
• D79111105: 5 oz. of Tilite (Omega)