Luminesse Shaded PMMA Discs

GUDID D7915298D30

TALLADIUM, INC.

Polymer-based dental model material

• Primary Device ID: D7915298D30
• NIH Device Record Key: c9fe0689-4cc0-4eba-bfce-8e9b6d760980
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Shaded PMMA Discs
• Version Model Number: 5298D3
• 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	D7915298D30 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142371

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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 Shaded PMMA Discs]

• D7915308D40: 5308D4
• D7915308D30: 5308D3
• D7915308D20: 5308D2
• D7915308D10: 5308D1
• D7915308C40: 5308C4
• D7915308C30: 5308C3
• D7915308C20: 5308C2
• D7915308C10: 5308C1
• D7915308B40: 5308B4
• D7915308B30: 5308B3
• D7915308B20: 5308B2
• D7915308B10: 5308B1
• D7915308A40: 5308-A4
• D7915308A350: 5308A35
• D7915308A30: 5308A3
• D7915308A20: 5308A2
• D7915308A10: 5308A1
• D7915308A00: 5308A0
• D7915307D40: 5307D4
• D7915307D30: 5307D3
• D7915307D20: 5307D2
• D7915307D10: 5307D1
• D7915307C40: 5307C4
• D7915307C30: 5307C3
• D7915307C20: 5307C2
• D7915307C10: 5307C1
• D7915307B40: 5307B4
• D7915307B30: 5307B3
• D7915307B20: 5307B2
• D7915307B10: 5307B1
• D7915307A40: 5307-A4
• D7915307A350: 5307A35
• D7915307A30: 5307A3
• D7915307A20: 5307A2
• D7915307A10: 5307A1
• D7915307A00: 5307A0
• D7915303A00: 5303-A0
• D7915301D40: 5301D4
• D7915301D30: 5301D3
• D7915301D20: 5301D2
• D7915301C40: 5301C4
• D7915301C30: 5301C3
• D7915301C20: 5301C2
• D7915301C10: 5301C1
• D7915301BL10: 5301-BL1
• D7915301B40: 5301B4
• D7915301B30: 5301B3
• D7915301B20: 5301B2
• D7915301B10: 5301B1
• D7915301A40: 5301A4