Cleared Traditional

K202523 - TMJ Relax

K202523 · Moonwalker Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K202523

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.

OCO Device Classification - Class 0,

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.