Luminesse HF Opacious Dentins

GUDID D7911962D20

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D7911962D20
• NIH Device Record Key: d794a0dd-c502-421a-8d5b-506cc0350724
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse HF Opacious Dentins
• Version Model Number: 1962D2
• 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	D7911962D20 [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

On-Brand Devices [Luminesse HF Opacious Dentins]

• D7911962D40: 1962D4
• D7911962D30: 1962D3
• D7911962D20: 1962D2
• D7911962C40: 1962C4
• D7911962C30: 1962C3
• D7911962C20: 1962C2
• D7911962C10: 1962C1
• D7911962B40: 1962B4
• D7911962B30: 1962B3
• D7911962B20: 1962B2
• D7911962B10: 1962B1
• D7911962A40: 1962A4
• D7911962A350: 1962A35
• D7911962A30: 1962A3
• D7911962A20: 1962A2
• D7911962A10: 1962A1