Luminesse LF Opaque Powder

GUDID D7911913A00

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D7911913A00
• NIH Device Record Key: 47ff1c16-2470-4998-b9b4-c1d3a6969981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse LF Opaque Powder
• Version Model Number: 1913A0
• 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	D7911913A00 [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 LF Opaque Powder]

• D7911913D40: 1913D4
• D7911913D30: 1913D3
• D7911913D20: 1913D2
• D7911913C40: 1913C4
• D7911913C30: 1913C3
• D7911913C20: 1913C2
• D7911913C10: 1913C1
• D7911913B40: 1913B4
• D7911913B30: 1913B3
• D7911913B20: 1913B2
• D7911913B10: 1913B1
• D7911913B00: 1913B0
• D7911913A40: 1913A4
• D7911913A30: 1913A3
• D7911913A20: 1913A2
• D7911913A10: 1913A1
• D7911913A00: 1913A0