Home / 510(k) Clearances / K112787

510(k) K112787

KERATOR by Kj Meditech Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2012
Date Received
September 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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)
  • K151970 — KJ Mini Implant System (October 21, 2016)
  • 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)
  • K103810 — KJ SUBMERGED SYSTEM (September 14, 2011)

Other clearances for product code NHA

  • K251434 — Healing Abutment System (March 4, 2026)
  • K251515 — Solidex® Ti-Links and Screws (February 10, 2026)
  • K251427 — EK MULTI ANGLED 30 ABUTMENT (January 29, 2026)
  • K243732 — Multi-Unit DAS System (January 29, 2026)
  • K253253 — IPDmilled Blanks (January 22, 2026)
  • K253315 — Straumann Variobase Abutments XC for Bridge/Bar (January 22, 2026)
  • K252727 — Neodent InLab Validated Workflow (January 7, 2026)
  • K253341 — Custom Abutments AS (December 23, 2025)
  • K253312 — OrangeCAD Med Abutments (December 23, 2025)
  • K252320 — SIMDA Abutments (December 18, 2025)