Cleared Traditional

K241369 - LIJIA Night Guard (FDA 510(k) Clearance)

K241369 · Lijia, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
100d
Days
-
Risk

K241369 is an FDA 510(k) clearance for the LIJIA Night Guard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Lijia, LLC (Santa Ana, US). The FDA issued a Cleared decision on August 22, 2024 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lijia, LLC devices

Submission Details

510(k) Number K241369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Prime Path Medtech
Jennifer Day

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQC Mouthguard, Prescription

All 70
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K241369.
UltraPrint-Dental Hard Splint UV
K253798 · Guangzhou Heygears IMC., Inc. · Mar 2026
Remvia NightGuard
K250743 · Remvia · Dec 2025
NOBILCAM IMPAK Disc
K251252 · Shandong Huge Dental Material Corporation · Aug 2025
Hard Splint & Thermo-Adaptive Splint
K241729 · Whip Mix Corporation · Mar 2025
Remi Custom Night Guard
K243516 · Grindguard, Inc. · Feb 2025
GR Resin System MSI
K231775 · Pro3Dure Medical · Aug 2024