Cleared Traditional

K202523 - TMJ Relax (FDA 510(k) Clearance)

K202523 · Moonwalker Innovations, Inc. · Dental device
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Jun 2021
Decision
296d
Days
-
Risk

K202523 is an FDA 510(k) clearance for the TMJ Relax. Classified as Mouthguard, Migraine/tension Headache (product code OCO).

Submitted by Moonwalker Innovations, Inc. (Medford, US). The FDA issued a Cleared decision on June 24, 2021 after a review of 296 days - an extended review cycle.

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. Standard predicate reliance. 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 Moonwalker Innovations, Inc. devices

Submission Details

510(k) Number K202523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date June 24, 2021
Days to Decision 296 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
169d slower than avg
Panel avg: 127d · This submission: 296d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OCO Mouthguard, Migraine/tension Headache
Device Class -
Definition A Device To Be Used In The Prophylactic Treatment Of Medically Diagnosed Migraine Pain As Well As Migraine Associated Tension-type Headaches, By Reducing Their Signs And Symptoms Through Reduction Of Trigeminally Innervated Muscular Activity, And; For The Prevention Of Bruxism And Tmj Syndrome Through Reduction Of Trigeminally Innervated Muscular Activity.