Luminesse HF Dentin Powder

GUDID D7911952C10

TALLADIUM, INC.

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

• Primary Device ID: D7911952C10
• NIH Device Record Key: a88ffbbf-9444-4f33-9dc3-a4c4d1264157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse HF Dentin Powder
• Version Model Number: 1952C1
• 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	D7911952C10 [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 Dentin Powder]

• D7911952D40: 1952D4
• D7911952D30: 1952D3
• D7911952D20: 1952D2
• D7911952C40: 1952C4
• D7911952C30: 1952C3
• D7911952C20: 1952C2
• D7911952C10: 1952C1
• D7911952B40: 1952B4
• D7911952B30: 1952B3
• D7911952B20: 1952B2
• D7911952B10: 1952B1
• D7911952B000: 1952B00
• D7911952B00: 1952B0
• D7911952A40: 1952A4
• D7911952A350: 1952A35
• D7911952A30: 1952A3
• D7911952A20: 1952A2
• D7911952A10: 1952A1
• D7911952A00: 1952A0