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FDA 510(k)

Invisalign System, Pre-Formed Attachment System

K-Number: K222894 · 2022-12-22

ApplicantAlign Technology, Inc.
Decision Date2022-12-22
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Invisalign System, Pre-Formed Attachment System is the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2022-12-22 under 510(k) number K222894. 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 Invisalign System, Pre-Formed Attachment System?

Invisalign System, Pre-Formed Attachment System is a medical device that received FDA 510(k) clearance on 2022-12-22. The listed applicant is Align Technology, Inc.. The 510(k) number is K222894.

When did Invisalign System, Pre-Formed Attachment System receive FDA 510(k) clearance?

Invisalign System, Pre-Formed Attachment System received FDA 510(k) clearance on 2022-12-22, under 510(k) number K222894.

Who is the listed applicant for Invisalign System, Pre-Formed Attachment System?

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

What is the FDA product code for Invisalign System, Pre-Formed Attachment System?

The FDA product code for Invisalign System, Pre-Formed Attachment System is NXC.

Related Clinical Trials

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.

NCT06814262Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral IncisorsCOMPLETED

Other records listing Align Technology, Inc. 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.

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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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