Luminesse ZR Dentin Powder

GUDID D7911972C40

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D7911972C40
• NIH Device Record Key: bd09a2d1-b870-45f5-bbff-6eadc1ab8671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse ZR Dentin Powder
• Version Model Number: 1972C4
• 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	D7911972C40 [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 ZR Dentin Powder]

• D7911972D40: 1972D4
• D7911972D30: 1972D3
• D7911972D20: 1972D2
• D7911972C40: 1972C4
• D7911972C30: 1972C3
• D7911972C20: 1972C2
• D7911972C10: 1972C1
• D7911972B40: 1972B4
• D7911972B30: 1972B3
• D7911972B20: 1972B2
• D7911972B10: 1972B1
• D7911972B000: 1972B00
• D7911972B00: 1972B0
• D7911972A40: 1972A4
• D7911972A350: 1972A35
• D7911972A30: 1972A3
• D7911972A20: 1972A2
• D7911972A10: 1972A1
• D7911972A00: 1972A0