Archform 1

GUDID 00860012168514

Archform Aligners and Retainers

Archform Inc.

Orthodontic progressive aligner

• Primary Device ID: 00860012168514
• NIH Device Record Key: 78828857-e945-4afa-8f43-6766a49e9c0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Archform
• Version Model Number: 1
• Catalog Number: 1
• Company DUNS: 119306995
• Company Name: Archform 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: 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
GS1	00860012168514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151965

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: 2025-07-30
• Device Publish Date: 2025-07-22

Devices Manufactured by Archform Inc.

• 00860012168514 - Archform: 2025-07-30Archform Aligners and Retainers
• 00860012168514 - Archform: 2025-07-30 Archform Aligners and Retainers
• 00860012168521 - Archform Orthodontic Software: 2025-07-30