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510(k) K173642

KLOCKNER SURGICAL BOX by SOADCO, S.L. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2018
Date Received
November 24, 2017
Clearance Type
Abbreviated
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 SOADCO, S.L.

  • K243128 — Klockner Kits (December 18, 2024)
  • K230103 — Klockner Abutments (April 24, 2023)
  • K170022 — Klockner Vega TiBase for CEREC (November 16, 2017)
  • K153098 — KLOCKNER VEGA DENTAL IMPLANT SYSTEM (April 8, 2016)
  • K151194 — KLOCKNER DENTAL IMPLANT ABUTMENTS (II) (January 29, 2016)
  • K122988 — KLOCKNER DENTAL IMPLANT ABUTMENTS (July 19, 2013)
  • K082200 — KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 (November 25, 2008)
  • K080224 — KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL (July 3, 2008)
  • K052654 — KLOCKNER DENTAL IMPLANT, MODEL S3M (January 30, 2006)
  • K010132 — KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 (June 4, 2002)

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  • 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)