Cleared Traditional

Remi Custom Night Guard

K243516 · Grindguard, Inc. · Dental

Feb 2025

Decision

89d

Days

—

Risk

About This 510(k) Submission

K243516 is an FDA 510(k) clearance for the Remi Custom Night Guard, a Mouthguard, Prescription, submitted by Grindguard, Inc. (San Francisco, US). The FDA issued a Cleared decision on February 10, 2025, 89 days after receiving the submission on November 13, 2024. This device falls under the Dental review panel.

Submission Details

510(k) Number	K243516 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2024
Decision Date	February 10, 2025
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF