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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 the device name listed in this FDA 510(k) record. The listed applicant is Argen Corporation. It received FDA 510(k) clearance on 2020-02-10 under 510(k) 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. The listed applicant is Argen Corporation. The 510(k) number is K192846.

When did Argen Clear Aligner, Argen Clear Aligner Premium receive FDA 510(k) clearance?

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

Who is the listed applicant for Argen Clear Aligner, Argen Clear Aligner Premium?

The FDA 510(k) record lists Argen Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Argen Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242458ArgenZ MTZK183229Argen Clear AlignerK172430ArgenIS Titanium AbutmentsK160248ArgenIS Titanium Abutments

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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