Tilite Ceramic Alloys - Premium

GUDID D79110005

5 oz of Tilite (Premium)

TALLADIUM, INC.

Dental casting non-noble alloy

• Primary Device ID: D79110005
• NIH Device Record Key: 8e52419b-2224-4ad9-b395-bcb9d6c931ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tilite Ceramic Alloys - Premium
• Version Model Number: 100-5
• 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	D79110005 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Tilite Ceramic Alloys - Premium]

• D791200: 120
• D7911000: 100
• D79110005: 5 oz of Tilite (Premium)