Luminesse ZR Trial Kit

GUDID D7911972T0

TALLADIUM, INC.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: D7911972T0
• NIH Device Record Key: bc59ffe6-8a12-4d98-aab5-e67d4df0dc99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse ZR Trial Kit
• Version Model Number: 1972T
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7911972T0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140848

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-24
• Device Publish Date: 2016-10-24

Devices Manufactured by TALLADIUM, INC.

• D79119510OFA0 - Luminesse Zirconia Discs: 2023-04-05 95 x 10 mm
• D79119518OFA0 - Luminesse Zirconia Discs: 2023-04-05 95 x 18 mm
• D79119530OFA0 - Luminesse Zirconia Discs: 2023-04-05 95 x 30
• D79110005 - Tilite Ceramic Alloys - Premium: 2022-12-07 5 oz of Tilite (Premium)
• 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)
• D791CLOFADG0 - Color Liquid: 2022-11-25 Dark Gray (Color)