Cleared Traditional

Goyo Mouthpiece S

K232238 · Dimedikorea · Dental
Apr 2024
Decision
264d
Days
—
Risk

About This 510(k) Submission

K232238 is an FDA 510(k) clearance for the Goyo Mouthpiece S, a Mouthguard, Over-the-counter, submitted by Dimedikorea (Busan, KR). The FDA issued a Cleared decision on April 17, 2024, 264 days after receiving the submission on July 28, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number K232238 FDA.gov
FDA Decision Cleared 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

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.