Cleared Traditional

K230548 - Myoaligner Appliance (FDA 510(k) Clearance)

K230548 · Myohealth Technologies, LLC · Dental device

Feb 2024

Decision

339d

Days

Risk

K230548 is an FDA 510(k) clearance for the Myoaligner Appliance. This device is classified as a Mouthguard, Prescription.

Submitted by Myohealth Technologies, LLC (Portland, US). The FDA issued a Cleared decision on February 2, 2024, 339 days after receiving the submission on February 28, 2023.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K230548 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 28, 2023
Decision Date	February 02, 2024
Days to Decision	339 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF