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510(k) K250743

Remvia NightGuard by Remvia — Product Code MQC

K250743 is an FDA 510(k) premarket notification submitted by Remvia for the device "Remvia NightGuard". The FDA issued a decision of Substantially Equivalent on December 5, 2025. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2025
Date Received
March 11, 2025
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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  • K251252 — NOBILCAM IMPAK Disc (August 1, 2025)
  • K241729 — Hard Splint & Thermo-Adaptive Splint (March 18, 2025)
  • K243516 — Remi Custom Night Guard (February 10, 2025)
  • K241369 — LIJIA Night Guard (August 22, 2024)
  • 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