ArgenZ GT 98x20 B1 137890

GUDID D818137890

Dental ceramic materials for fabrication of dental restorations

ARGEN CORPORATION, THE

Dental appliance fabrication material, ceramic

• Primary Device ID: D818137890
• NIH Device Record Key: 4912f2ba-20da-4e97-9ce7-f878510f2445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArgenZ GT 98x20 B1
• Version Model Number: 137890
• Catalog Number: 137890
• Company DUNS: 103095543
• Company Name: ARGEN CORPORATION, THE
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-255-5524
• Email: customersuccess@argen.com
• Phone: 1-800-255-5524
• Email: customersuccess@argen.com
• Phone: 1-800-255-5524
• Email: customersuccess@argen.com
• Phone: 1-800-255-5524
• Email: customersuccess@argen.com
• Phone: 1-800-255-5524
• Email: customersuccess@argen.com
• Phone: 1-800-255-5524
• Email: customersuccess@argen.com
• Phone: 1-800-255-5524
• Email: customersuccess@argen.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D818137890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242458

FDA Product Code

• EIH: Powder, Porcelain

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-23
• Device Publish Date: 2026-01-15

Devices Manufactured by ARGEN CORPORATION, THE

• D818137839 - ArgenZ GT 98x12 A1: 2026-01-23 Dental ceramic materials for fabrication of dental restorations
• D818137840 - ArgenZ GT 98x12 A2: 2026-01-23 Dental ceramic materials for fabrication of dental restorations
• D818137841 - ArgenZ GT 98x12 A3: 2026-01-23 Dental ceramic materials for fabrication of dental restorations
• D818137849 - ArgenZ GT 98x16 A1: 2026-01-23 Dental ceramic materials for fabrication of dental restorations
• D818137850 - ArgenZ GT 98x16 A2: 2026-01-23 Dental ceramic materials for fabrication of dental restorations
• D818137851 - ArgenZ GT 98x16 A3: 2026-01-23 Dental ceramic materials for fabrication of dental restorations
• D818137859 - ArgenZ GT 98x20 A1: 2026-01-23 Dental ceramic materials for fabrication of dental restorations
• D818137860 - ArgenZ GT 98x20 A2: 2026-01-23 Dental ceramic materials for fabrication of dental restorations