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510(k) K232238

Goyo Mouthpiece S by Dimedikorea — Product Code OBR

K232238 is an FDA 510(k) premarket notification submitted by Dimedikorea for the device "Goyo Mouthpiece S". The FDA issued a decision of Substantially Equivalent on April 17, 2024. The device falls under product code OBR (Mouthguard, Over-The-Counter), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2024
Date Received
July 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Over-The-Counter
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.

Other clearances for product code OBR

  • K260790 — G-Series Grind Guard (June 25, 2026)
  • K252485 — ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); Clench (April 10, 2026)
  • K253641 — Owl Night Guard (February 26, 2026)
  • K252004 — enCore Night Guard (November 25, 2025)
  • K251778 — Remi Custom Night Guard (October 17, 2025)
  • K250456 — Dentemp Pro-Comfort Dental Guard (May 19, 2025)
  • K240810 — Anti Grinding Guard (May 24, 2024)
  • K231865 — Mouth Guard (ATG0603R) (November 6, 2023)
  • K221369 — FBCC Night Guard (November 18, 2022)
  • K222424 — Protect-It Custom Fit Dental Guard (October 7, 2022)

FDA data resources