Home / 510(k) Clearances / K201688

510(k) K201688

S.I.N. Instrument Kits by S.I.N. - Sistema DE Implante Nacional S.A. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2020
Date Received
June 22, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by S.I.N. - Sistema DE Implante Nacional S.A.

  • K240609 — S.I.N. Dental Implant System (July 17, 2024)
  • K241378 — S.I.N. Instrument Kits (July 12, 2024)
  • K232821 — S.I.N. Dental Implant System (May 31, 2024)
  • K231127 — S.I.N. Dental Implant System (December 7, 2023)
  • K222231 — S.I.N. Dental Implant System (October 27, 2022)
  • K222005 — S.I.N. Instrument Kits (September 29, 2022)
  • K212404 — S.I.N. Instrument Kits (November 3, 2021)
  • K211921 — S.I.N. Dental Implant System (October 20, 2021)
  • K203725 — S.I.N. Dental Implant System (June 23, 2021)
  • K200992 — S.I.N. Dental Implant System (November 17, 2020)

Other clearances for product code KCT

  • K253791 — PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula Syste (February 26, 2026)
  • K251614 — Stainless Steel Surgical Kits (February 6, 2026)
  • K251756 — Sterilization Trays (November 14, 2025)
  • K243425 — Guided DAS Surgical Kit (July 22, 2025)
  • K251300 — Plastic Surgical Kits (July 22, 2025)
  • K243589 — PAL Sterilization Case (June 20, 2025)
  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K250029 — ONE TRAY® Sealed Sterilization Container System (May 1, 2025)
  • K241927 — Synthes Graphic Case & Tray System (March 28, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)