Luminesse Low Fusing Dentin Powder

GUDID D7911902B00

TALLADIUM, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: D7911902B00
• NIH Device Record Key: 0648bd4a-d0f9-4c3b-b6c4-357ec1ebeed3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Low Fusing Dentin Powder
• Version Model Number: 1902B0
• 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	D7911902B00 [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 Low Fusing Dentin Powder]

• D7911902D40: 1902D4
• D7911902D30: 1902D3
• D7911902D20: 1902D2
• D7911902C40: 1902C4
• D7911902C30: 1902C3
• D7911902C20: 1902C2
• D7911902C10: 1902C1
• D7911902B40: 1902B4
• D7911902B30: 1902B3
• D7911902B20: 1902B2
• D7911902B10: 1902B1
• D7911902B000: 1902B00
• D7911902B00: 1902B0
• D7911902A40: 1902A4
• D7911902A350: 1902A35
• D7911902A30: 1902A3
• D7911902A20: 1902A2
• D7911902A10: 1902A1
• D7911902A000: 1902A00
• D7911902A00: 1902A0