Luminesse Shaded PMMA Discsq

GUDID D7915299C10

TALLADIUM, INC.

Polymer-based dental model material

• Primary Device ID: D7915299C10
• NIH Device Record Key: 295fad97-4341-44e5-bc34-e2e3dfa7254f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Shaded PMMA Discsq
• Version Model Number: 5299C1
• 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	D7915299C10 [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

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