Luminesse ZR Dentin Modifiers

GUDID D7911978Y0

TALLADIUM, INC.

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: D7911978Y0
• NIH Device Record Key: 6cc62b3d-d4e8-41c6-8742-6eed357f1ff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse ZR Dentin Modifiers
• Version Model Number: 1978Y
• 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	D7911978Y0 [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 Modifiers]

• D7911978Y0: 1978Y
• D7911978OC0: 1978OC
• D7911978O0: 1978O
• D7911978I0: 1978I