Home / 510(k) Clearances / K123582

510(k) K123582

ENDO A CLASS by Saeyang Microtech Co., Ltd. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2013
Date Received
November 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Saeyang Microtech Co., Ltd.

  • K213897 — Pro M Class (September 19, 2022)
  • K141482 — KI-20 (April 24, 2015)
  • K123608 — ENDO E CLASS (August 16, 2013)

Other clearances for product code EKX

  • K252223 — Alpha Endo Handpiece (Alpha Endo) (October 16, 2025)
  • K251597 — InnerView System (September 18, 2025)
  • K243692 — EnDrive (EnDriveUS) (August 22, 2025)
  • K242514 — Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) (April 24, 2025)
  • K241065 — ChecQ (AC100) (March 21, 2025)
  • K243911 — HPR Cordless Hygiene Handpiece (December 20, 2024)
  • K222688 — The Trust (August 9, 2024)
  • K233865 — X-Smart Pro; X-Smart Pro+ (July 24, 2024)
  • K232551 — EM-07 Cordless Endo Motor (July 9, 2024)
  • K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit (November 9, 2023)