Luminesse Universal Stain Shades

GUDID D7911906Y0

TALLADIUM, INC.

Dental prosthesis dye

• Primary Device ID: D7911906Y0
• NIH Device Record Key: 106b3c73-caea-436d-8bef-878bb8748680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Universal Stain Shades
• Version Model Number: 1906Y
• 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	D7911906Y0 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-24

On-Brand Devices [Luminesse Universal Stain Shades]

• D7911906Y0: 1906Y
• D7911906W0: 1906W
• D7911906OL0: 1906OL
• D7911906O0: 1906O
• D7911906LB0: 1906LB
• D7911906GY0: 1906GY
• D7911906DP0: 1906DP
• D7911906DBL0: 1906DBL
• D7911906DB0: 1906DB
• D7911906D0: 1906D
• D7911906C0: 1906C
• D7911906BL0: 1906BL
• D7911906B0: 1906B
• D7911906A0: 1906A