Cleared Traditional

Mouth Guard (ATG0603R)

K231865 · Reazeal Corp · Dental
Nov 2023
Decision
133d
Days
—
Risk

About This 510(k) Submission

K231865 is an FDA 510(k) clearance for the Mouth Guard (ATG0603R), a Mouthguard, Over-the-counter, submitted by Reazeal Corp (Wilmington, US). The FDA issued a Cleared decision on November 6, 2023, 133 days after receiving the submission on June 26, 2023. This device falls under the Dental review panel.

Submission Details

510(k) Number K231865 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2023
Decision Date November 06, 2023
Days to Decision 133 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.