Cleared Traditional

LIJIA Night Guard

K241369 · Lijia, LLC · Dental

Aug 2024

Decision

100d

Days

—

Risk

About This 510(k) Submission

K241369 is an FDA 510(k) clearance for the LIJIA Night Guard, a Mouthguard, Prescription, submitted by Lijia, LLC (Santa Ana, US). The FDA issued a Cleared decision on August 22, 2024, 100 days after receiving the submission on May 14, 2024. This device falls under the Dental review panel.

Submission Details

510(k) Number	K241369 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2024
Decision Date	August 22, 2024
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF