Identifiers
- 510(k) Number
- K183229 FDA 510(k)
- FDA Product Code
- NXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5470 FDA 510(k)
- Regulation Number
- 872.5470 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Argen Clear Aligner is a removable dental appliance classified as a sequential aligner, designed to gradually reposition teeth for orthodontic correction. It is intended for use in treating anterior and premolar malocclusion, providing a clear, esthetic alternative to traditional braces.
These aligners are supplied as single-use, non-sterile devices and are manufactured from thermoformed plastic material. They are intended for use in dental offices and laboratories, with sizes and configurations tailored to individual patient needs. The device holds an FDA 510(k) clearance under the classification of Class II (NXC), with registration numbers including 2082148 and others listed. Storage and handling follow standard dental practice guidelines.
Frequently asked questions
Are the Argen Clear Aligners reusable or designed for single-use only?
The Argen Clear Aligners are explicitly designed for single-use only. This aligns with standard dental practice guidelines for removable orthodontic appliances, ensuring patient safety and hygiene by preventing cross-contamination between patients.
What types of malocclusions can the Argen Clear Aligner treat?
The Argen Clear Aligner is specifically intended for treating anterior and premolar malocclusion. It provides a clear, aesthetic alternative to traditional braces for gradual tooth repositioning, making it suitable for patients seeking discreet orthodontic correction.
How are the Argen Clear Aligners supplied, and do they come in standard sizes?
The Argen Clear Aligners are supplied as custom-fabricated, thermoformed plastic devices tailored to individual patient needs. While they are not pre-sized, their sizes and configurations are determined through dental impressions or scans to ensure a precise fit for each patient’s specific malocclusion.
Do the Argen Clear Aligners require any special storage or handling instructions?
The Argen Clear Aligners follow standard dental practice guidelines for storage and handling. Since they are non-sterile and single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for removable dental appliances.
What is the regulatory pathway for the Argen Clear Aligner, and how can I verify its clearance?
The Argen Clear Aligner holds FDA 510(k) clearance under the classification of Class II (product code NXC) with registration numbers like 2082148. It was determined to be substantially equivalent to a predicate device through a traditional review process by the FDA’s Dental Advisory Committee (DE). For verification, you can reference the FDA’s OpenFDA database or the manufacturer’s official documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Clear Aligners - Argen, Argen Clear Aligners, Argen Clear Aligners: Getting Started with Argen - The Dental Lab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183229 | Class II | Active |
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Manufacturer
- Manufacturer
- Argen Corporation
Sources (1)
- FDA 510(k) K183229 24 fields · synced Sep 19, 2026