Luminesse Super Clear PMMA Discs

GUDID D79153290

TALLADIUM, INC.

Polymer-based dental model material

• Primary Device ID: D79153290
• NIH Device Record Key: 1520c8e8-1838-49d4-80e9-05b17af9e70c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Super Clear PMMA Discs
• Version Model Number: 5329
• 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	D79153290 [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 Super Clear PMMA Discs]

• D79153420: 5342
• D79153320: 5332
• D79153290: 5329