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510(k) K230592

LuxCreo Dental Night Guard Resin by LuxCreo, Inc. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2024
Date Received
March 3, 2023
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 by LuxCreo, Inc.

  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K250343 — LuxCreo Clear Aligner System (April 8, 2025)
  • K212680 — LuxCreo Clear Aligner System (May 31, 2022)

Other clearances for product code MQC

  • K253798 — UltraPrint-Dental Hard Splint UV (March 2, 2026)
  • 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)
  • 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)