Home / 510(k) Clearances / K151970

510(k) K151970

KJ Mini Implant System by Kj Meditech Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2016
Date Received
July 16, 2015
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 Kj Meditech Co., Ltd.

  • K202046 — LOTA SLA Dental Implant System and LOTA HA Dental Implant System (March 1, 2022)
  • K173116 — KJ ZIRCONIA Implant System (June 28, 2018)
  • K161923 — J2A SLA Dental Implant System (November 9, 2017)
  • K150060 — J2A Dental Implant System, J2C Dental Implant System (April 2, 2015)
  • K140051 — KJ EXTERNAL IMPLANT SYSTEM (October 30, 2014)
  • K140052 — J2I IMPLANT SYSTEM (October 30, 2014)
  • K121098 — HERO I DENTAL IMPLANT SYSTEM (January 17, 2013)
  • K121047 — HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM (October 4, 2012)
  • K112787 — KERATOR (August 8, 2012)
  • K103810 — KJ SUBMERGED SYSTEM (September 14, 2011)

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)