Cleared Traditional

Remi Custom Night Guard

K251778 · Remi · Dental
Oct 2025
Decision
129d
Days
—
Risk

About This 510(k) Submission

K251778 is an FDA 510(k) clearance for the Remi Custom Night Guard, a Mouthguard, Over-the-counter, submitted by Remi (San Francisco, US). The FDA issued a Cleared decision on October 17, 2025, 129 days after receiving the submission on June 10, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number K251778 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2025
Decision Date October 17, 2025
Days to Decision 129 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.