Cleared Traditional

Owl Night Guard

K253641 · Owl Dental Lab, Inc. · Dental
Feb 2026
Decision
99d
Days
—
Risk

About This 510(k) Submission

K253641 is an FDA 510(k) clearance for the Owl Night Guard, a Mouthguard, Over-the-counter, submitted by Owl Dental Lab, Inc. (San Leandro, US). The FDA issued a Cleared decision on February 26, 2026, 99 days after receiving the submission on November 19, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number K253641 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2025
Decision Date February 26, 2026
Days to Decision 99 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.