Home / 510(k) Clearances / K220577

510(k) K220577

Dental Handpiece, Model CA160, CA160L, and CA500L by Micro-Nx Co., Ltd. — Product Code EGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
February 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Micro-Nx Co., Ltd.

  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K232810 — Dental Handpiece, Wireless Endodontic Handpiece, endoit (November 9, 2023)
  • K201191 — ELEC-LED (February 7, 2022)
  • K201192 — Impla-NX (Model: ISE-270M) (May 21, 2021)
  • K192809 — Dental Handpiece (August 25, 2020)
  • K161500 — MEG-TORQ (February 22, 2017)

Other clearances for product code EGS

  • K251869 — Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (September 15, 2025)
  • K240950 — Disposable Prophy Angle (May 28, 2025)
  • K240183 — Star E900 Handpiece Series (September 19, 2024)
  • K230106 — General Cutting Straight (May 24, 2023)
  • K222518 — FX Contra (November 17, 2022)
  • K220346 — Lotus Prophy Angle (November 7, 2022)
  • K220874 — Smooth Drive contra angle and straight handpieces (November 7, 2022)
  • K213139 — SURGmatic S15 L Pro (December 21, 2021)
  • K202960 — General Cutting Contra Handpiece (October 27, 2020)
  • K182892 — TRAUS Dental Handpieces (November 26, 2019)