Luminesse HF Opaque Paste

GUDID D7911951B10

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D7911951B10
• NIH Device Record Key: 15cd03a8-261f-4aa2-9046-355dae3ad047
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse HF Opaque Paste
• Version Model Number: 1951B1
• 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	D7911951B10 [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 Paste]

• D7911951D40: 1951D4
• D7911951D30: 1951D3
• D7911951D20: 1951D2
• D7911951C40: 1951C4
• D7911951C30: 1951C3
• D7911951C20: 1951C2
• D7911951C10: 1951C1
• D7911951B40: 1951B4
• D7911951B30: 1951B3
• D7911951B20: 1951B2
• D7911951B10: 1951B1
• D7911951B0: 1951B
• D7911951A40: 1951A4
• D7911951A350: 1951A35
• D7911951A30: 1951A3
• D7911951A20: 1951A2
• D7911951A10: 1951A1