Tilite Ceramic Alloys - "V" 121

GUDID D791210

TALLADIUM, INC.

Dental casting non-noble alloy

• Primary Device ID: D791210
• NIH Device Record Key: 0f97a00c-f719-4b19-9dae-925a9fd83de2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tilite Ceramic Alloys - "V"
• Version Model Number: 121
• Catalog Number: 121
• 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: 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	D791210 [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: 2019-02-28
• Device Publish Date: 2019-01-28

Devices Manufactured by TALLADIUM, INC.

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• D79110105 - Tilite Ceramic Alloys - Vita: 2022-12-07 5 oz of Tilite (Vita)
• D79110205 - Tilite Ceramic Alloys - Star: 2022-12-07 5 oz of Tilite (Star)
• D79111105 - Tilite Ceramic Alloys - Omega: 2022-12-07 5 oz. of Tilite (Omega)
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