Cleared Traditional

K250743 - Remvia NightGuard (FDA 510(k) Clearance)

K250743 · Remvia · Dental device

Dec 2025

Decision

269d

Days

Risk

K250743 is an FDA 510(k) clearance for the Remvia NightGuard. This device is classified as a Mouthguard, Prescription.

Submitted by Remvia (St. Louis, US). The FDA issued a Cleared decision on December 5, 2025, 269 days after receiving the submission on March 11, 2025.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K250743 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 11, 2025
Decision Date	December 05, 2025
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF