FDA 510(k)

Myoaligner Appliance

K-Number: K230548 · 2024-02-02

Decision Date2024-02-02

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

Myoaligner Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Myohealth Technologies, LLC. It received FDA 510(k) clearance on 2024-02-02 under 510(k) number K230548. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Myoaligner Appliance?

Myoaligner Appliance is a medical device that received FDA 510(k) clearance on 2024-02-02. The listed applicant is Myohealth Technologies, LLC. The 510(k) number is K230548.

When did Myoaligner Appliance receive FDA 510(k) clearance?

Myoaligner Appliance received FDA 510(k) clearance on 2024-02-02, under 510(k) number K230548.

Who is the listed applicant for Myoaligner Appliance?

The FDA 510(k) record lists Myohealth Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myoaligner Appliance?

The FDA product code for Myoaligner Appliance is MQC.

Related Devices (Code: MQC)

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.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Official Source

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