retainer 125300

GUDID D818125300

orthodontic retainer

ARGEN CORPORATION, THE

Orthodontic retainer

• Primary Device ID: D818125300
• NIH Device Record Key: 9d19942e-4f73-44cd-9cdf-25dcd6b75db1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: retainer
• Version Model Number: Argen retainer Premium
• Catalog Number: 125300
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D818125300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183229

FDA Product Code

• NXC: Aligner, Sequential

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: 2020-03-27
• Device Publish Date: 2020-03-19

Devices Manufactured by ARGEN CORPORATION, THE

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• 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