Luminesse Multi-Layer PMMA Discs

GUDID D7915396A00

TALLADIUM, INC.

Polymer-based dental model material

• Primary Device ID: D7915396A00
• NIH Device Record Key: c43d3b6b-01b3-4d27-889c-427dd727f77e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luminesse Multi-Layer PMMA Discs
• Version Model Number: 5396A0
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7915396A00 [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 Multi-Layer PMMA Discs]

• D7915396D40: 5396D4
• D7915396D30: 5396D3
• D7915396D20: 5396D2
• D7915396C40: 5396C4
• D7915396C30: 5396C3
• D7915396C20: 5396C2
• D7915396C10: 5396C1
• D7915396B40: 5396B4
• D7915396B30: 5396B3
• D7915396B20: 5396B2
• D7915396B10: 5396B1
• D7915396A40: 5396A4
• D7915396A350: 5396A35
• D7915396A30: 5396A3
• D7915396A20: 5396A2
• D7915396A10: 5396A1
• D7915396A00: 5396A0
• D7915336D40: 5336D4
• D7915336D30: 5336D3
• D7915336D20: 5336D2
• D7915336C40: 5336C4
• D7915336C30: 5336C3
• D7915336C20: 5336C2
• D7915336C10: 5336C1
• D7915336B40: 5336B4
• D7915336B30: 5336B3
• D7915336B20: 5336B2
• D7915336B10: 5336B1
• D7915336A40: 5336A4
• D7915336A350: 5336A35
• D7915336A30: 5336A3
• D7915336A20: 5336A2
• D7915336A10: 5336A1
• D7915336A00: 5336A0
• D7915330C30: 5330C3
• D7915320D40: 5320D4
• D7915320D30: 5320D3
• D7915320D20: 5320D2
• D7915320C40: 5320C4
• D7915320C30: 5320-C3
• D7915320C20: 5320C2
• D7915320C10: 5320C1
• D7915320B40: 5320B4
• D7915320B30: 5320B3
• D7915320B20: 5320B2
• D7915320B10: 5320B1
• D7915320A40: 5320A4
• D7915320A350: 5320A35
• D7915320A30: 5320A3
• D7915320A20: 5320A2