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FDA 510(k)

Argen Clear Aligner, Argen Clear Aligner Premium

K-Number: K192846 · 2020-02-10

ApplicantArgen Corporation
Decision Date2020-02-10
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Argen Clear Aligner, Argen Clear Aligner Premium is a medical device manufactured by Argen Corporation. It received FDA 510(k) clearance on 2020-02-10 under approval number K192846. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Argen Clear Aligner, Argen Clear Aligner Premium?

Argen Clear Aligner, Argen Clear Aligner Premium is a medical device that received FDA 510(k) clearance on 2020-02-10. It is manufactured by Argen Corporation. The 510(k) number is K192846.

When was Argen Clear Aligner, Argen Clear Aligner Premium approved by the FDA?

Argen Clear Aligner, Argen Clear Aligner Premium received FDA 510(k) clearance on 2020-02-10, under approval number K192846.

What company makes Argen Clear Aligner, Argen Clear Aligner Premium?

Argen Clear Aligner, Argen Clear Aligner Premium is manufactured by Argen Corporation.

What is the FDA product code for Argen Clear Aligner, Argen Clear Aligner Premium?

The FDA product code for Argen Clear Aligner, Argen Clear Aligner Premium is NXC.

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT07420777 Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite RECRUITING

Other Devices by Argen Corporation

K160248ArgenIS Titanium Abutments K172430ArgenIS Titanium Abutments K183229Argen Clear Aligner K242458ArgenZ MTZ

Related Devices (Code: NXC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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