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FDA 510(k)

FACE4D Aligner

K-Number: K260527 · 2026-07-02

ApplicantAvinent Implant System S.L.U.
Decision Date2026-07-02
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FACE4D Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Avinent Implant System S.L.U.. It received FDA 510(k) clearance on 2026-07-02 under 510(k) number K260527. 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 FACE4D Aligner?

FACE4D Aligner is a medical device that received FDA 510(k) clearance on 2026-07-02. The listed applicant is Avinent Implant System S.L.U.. The 510(k) number is K260527.

When did FACE4D Aligner receive FDA 510(k) clearance?

FACE4D Aligner received FDA 510(k) clearance on 2026-07-02, under 510(k) number K260527.

Who is the listed applicant for FACE4D Aligner?

The FDA 510(k) record lists Avinent Implant System S.L.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FACE4D Aligner?

The FDA product code for FACE4D Aligner is NXC.

Other records listing Avinent Implant System S.L.U. 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.

K201533Avinent Biomimetic Coral and Ocean-Iceberg Sterilization CassettesK191566Avinent Surgical Tray

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.

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 GmbHK252931Invisalign® Palatal Expander SystemAlign Technology, Inc.

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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