FDA 510(k)

AsoAligner

K-Number: K201104 · 2021-02-26

Decision Date2021-02-26

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AsoAligner is the device name listed in this FDA 510(k) record. The listed applicant is Aso International Manila, Inc.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K201104. 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 AsoAligner?

AsoAligner is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is Aso International Manila, Inc.. The 510(k) number is K201104.

When did AsoAligner receive FDA 510(k) clearance?

AsoAligner received FDA 510(k) clearance on 2021-02-26, under 510(k) number K201104.

Who is the listed applicant for AsoAligner?

The FDA 510(k) record lists Aso International Manila, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AsoAligner?

The FDA product code for AsoAligner is NXC.

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) Limited K250739Primeprint 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.