Cleared Traditional

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

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

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
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.

Device Classification

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 40
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K230548.
Slow Wave DS8 (SWDS802)
K240463 · Slow Wave, Inc. · Jun 2024
RODIN 3D Resin SPLINT, Hard/Flex
K231793 · Belport Company, Inc., Gingi-Pak · Mar 2024
Dental LT Comfort Resin
K232087 · Formlabs Ohio, Inc. · Feb 2024
LuxCreo Dental Night Guard Resin
K230592 · LuxCreo, Inc. · Jan 2024
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
K222845 · Frey Oral Technologies, LLC · Nov 2023
Serena Sleep Night Guard
K230495 · Meris Investment Group · Oct 2023