Home / 510(k) Clearances / K240463

510(k) K240463

Slow Wave DS8 (SWDS802) by Slow Wave, Inc. — Product Code MQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2024
Date Received
February 16, 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 by Slow Wave, Inc.

  • K191320 — Slow Wave DS8 (October 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)
  • K231793 — RODIN 3D Resin SPLINT, Hard/Flex (March 26, 2024)
  • K232087 — Dental LT Comfort Resin (February 16, 2024)