template 127467

GUDID D818127467

template for aligner

ARGEN CORPORATION, THE

Orthodontic appliance system, progressive

• Primary Device ID: D818127467
• NIH Device Record Key: 945dd6d9-588f-4a02-b09b-2314561d70ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: template
• Version Model Number: Argen template Premium
• Catalog Number: 127467
• 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	D818127467 [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

• D818131367 - ArgenIS: 2024-03-18 TiBase AO WP 0.9G NE
• D818131599 - ArgenIS: 2023-05-05 MUA ZS RP 2.5GH Ang17
• D818131601 - ArgenIS: 2023-05-05 MUA ZS RP 3.5GH Ang17
• D818131603 - ArgenIS: 2023-05-05 MUA ZS RP 3.5GH Ang30
• D818131605 - ArgenIS: 2023-05-05 MUA ZS RP 4.5GH Ang30
• D818131709 - ArgenIS: 2023-05-05 TiBase MA 3.0G NE
• D818131710 - ArgenIS: 2023-05-05 TiBase MA 3.0G E
• D818131483 - ArgenIS: 2023-03-17 TiBase NR RP .3G NE