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510(k) K241369

LIJIA Night Guard by Lijia, LLC — Product Code MQC

K241369 is an FDA 510(k) premarket notification submitted by Lijia, LLC for the device "LIJIA Night Guard". The FDA issued a decision of Substantially Equivalent on August 22, 2024. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2024
Date Received
May 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthguard, Prescription
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances for product code MQC

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  • K250743 — Remvia NightGuard (December 5, 2025)
  • K251252 — NOBILCAM IMPAK Disc (August 1, 2025)
  • K241729 — Hard Splint & Thermo-Adaptive Splint (March 18, 2025)
  • K243516 — Remi Custom Night Guard (February 10, 2025)
  • K231775 — GR Resin System MSI (August 8, 2024)
  • K241311 — Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B) (August 2, 2024)
  • K240463 — Slow Wave DS8 (SWDS802) (June 4, 2024)
  • K231793 — RODIN 3D Resin SPLINT, Hard/Flex (March 26, 2024)
  • K232087 — Dental LT Comfort Resin (February 16, 2024)

FDA data resources