Home / 510(k) Clearances / K010132

510(k) K010132

KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 by SOADCO, S.L. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2002
Date Received
January 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by SOADCO, S.L.

  • K243128 — Klockner Kits (December 18, 2024)
  • 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)

Other clearances for product code DZE

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253493 — Dentis SQ-SL AXEL Fixture (March 4, 2026)
  • K252197 — Nobel Biocare S Series Implants (February 18, 2026)
  • K252286 — BIORES Dental Implant System (February 2, 2026)
  • K252585 — ZENEX Implant System_R-System (January 8, 2026)
  • K250476 — NizPlant Dental Implant System (December 23, 2025)
  • K252145 — GEN5™ and GEN5+™ 3.3mmD Dental Implants (December 23, 2025)
  • K251605 — DIMPLO Implant System (December 22, 2025)
  • K252090 — Pterygoid Indication for GM Helix Implants (December 12, 2025)
  • K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System (November 7, 2025)