Cleared Traditional

Goyo Mouthpiece S (K232238) - FDA 510(k) Clearance

K232238 · Dimedikorea · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
264d
Days
-
Risk

K232238 is an FDA 510(k) clearance for the Goyo Mouthpiece S. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Dimedikorea (Busan, KR). The FDA issued a Cleared decision on April 17, 2024 after a review of 264 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 Dimedikorea devices

Submission Details

510(k) Number K232238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2023
Decision Date April 17, 2024
Days to Decision 264 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 127d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBR Mouthguard, Over-the-counter
Device Class -
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 19
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K232238.
Remi Custom Night Guard
K251778 · Remi · Oct 2025
Dentemp Pro-Comfort Dental Guard
K250456 · Doc Brands, Inc. · May 2025
Anti Grinding Guard
K240810 · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 2024
Mouth Guard (ATG0603R)
K231865 · Reazeal Corp · Nov 2023
FBCC Night Guard
K221369 · Fbcc, Inc. · Nov 2022
Protect-It Custom Fit Dental Guard
K222424 · Doc Brands, Inc. · Oct 2022