Luminesse HF Opaque Powder

GUDID D7911963B10

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D7911963B10
• NIH Device Record Key: 1e67ffc1-fdb0-4644-b298-ef8955b41466
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse HF Opaque Powder
• Version Model Number: 1963B1
• 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	D7911963B10 [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 Opaque Powder]

• D7911963D40: 1963D4
• D7911963D30: 1963D3
• D7911963D20: 1963D2
• D7911963C40: 1963C4
• D7911963C30: 1963C3
• D7911963C20: 1963C2
• D7911963C10: 1963C1
• D7911963B40: 1963B4
• D7911963B30: 1963B3
• D7911963B20: 1963B2
• D7911963B10: 1963B1
• D7911963B0: 1963B
• D7911963A40: 1963A4
• D7911963A350: 1963A35
• D7911963A30: 1963A3
• D7911963A20: 1963A2
• D7911963A10: 1963A1