Home / 510(k) Clearances / K210923

510(k) K210923

Southern Implants Instrument Trays by Southern Implants (Pty), Ltd. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2022
Date Received
March 29, 2021
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 Southern Implants (Pty), Ltd.

  • K232726 — External Hex Implant System (April 1, 2024)
  • K232418 — Single Platform SP1 Implant System (December 1, 2023)
  • K230873 — Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (August 1, 2023)
  • K222469 — TIB Abutments (April 17, 2023)
  • K222457 — Provata Implant System (March 6, 2023)
  • K222497 — Zaga Zygomatic System (November 9, 2022)
  • K193084 — TIB Abutment System (October 27, 2020)
  • K192651 — ZAGA Zygomatic System (May 7, 2020)
  • K191054 — Southern Implants MAX Implant System (December 9, 2019)
  • K191250 — Southern Implants PEEK Abutments (December 5, 2019)

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)