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510(k) K243128

Klockner Kits by SOADCO, S.L. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2024
Date Received
September 30, 2024
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 SOADCO, S.L.

  • K230103 — Klockner Abutments (April 24, 2023)
  • K173642 — KLOCKNER SURGICAL BOX (October 2, 2018)
  • 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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  • 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)