Cleared Traditional

K230548 - Myoaligner Appliance

K230548 · Myohealth Technologies, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
339d
Days
-
Risk

K230548 is an FDA 510(k) clearance for the Myoaligner Appliance. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Myohealth Technologies, LLC (Portland, US). The FDA issued a Cleared decision on February 2, 2024 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Myohealth Technologies, LLC devices

FDA 510(k) Submission Details - K230548

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 127d · This submission: 339d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

The Eyedeas Company
Colette Cozean, Ph.D.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQC Mouthguard, Prescription

All 42
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