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510(k) K231793

RODIN 3D Resin SPLINT, Hard/Flex by Belport Company, Inc., Gingi-Pak — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2024
Date Received
June 20, 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 Belport Company, Inc., Gingi-Pak

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  • K250279 — RC-SwiftPrep (July 2, 2025)
  • K250222 — SDF Pro (May 7, 2025)
  • K240688 — RODIN Titan 3D Resin (June 20, 2024)
  • K231060 — ProMin Dental Desensitizing Gel (June 13, 2024)
  • K223365 — RODIN Palette Naturalizing Kit (March 27, 2023)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K200462 — EtchPro Etching Gel (September 2, 2020)

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)
  • K232087 — Dental LT Comfort Resin (February 16, 2024)