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510(k) K143655

SICAT OPTIMOTION by Sicat GmbH & Co. KG — Product Code MQC

K143655 is an FDA 510(k) premarket notification submitted by Sicat GmbH & Co. KG for the device "SICAT OPTIMOTION". The FDA issued a decision of Substantially Equivalent on October 2, 2015. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Sicat GmbH & Co. KG has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2015
Date Received
December 23, 2014
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 Sicat GmbH & Co. KG

  • K192348 — SICAT Implant V2.0 (December 4, 2019)
  • K180262 — SICAT Endo (March 12, 2018)
  • K153291 — SICAT OPTISLEEP (March 31, 2016)
  • K133320 — SICAT FUNCTION (February 25, 2014)
  • K103723 — SICAT IMPLANT V1.2 (May 20, 2011)
  • K093090 — GALILEOS IMPLANT, VERSION 1.7 (December 17, 2009)
  • K090119 — SICAT IMPLANT (February 5, 2009)
  • K061472 — GALILEOS IMPLANT, V 1.0 (June 9, 2006)

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)

FDA data resources