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510(k) K201192

Impla-NX (Model: ISE-270M) by Micro-Nx Co., Ltd. — Product Code EBW

K201192 is an FDA 510(k) premarket notification submitted by Micro-Nx Co., Ltd. for the device "Impla-NX (Model: ISE-270M)". The FDA issued a decision of Substantially Equivalent on May 21, 2021. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Micro-Nx Co., Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2021
Date Received
May 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
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)
  • K220577 — Dental Handpiece, Model CA160, CA160L, and CA500L (July 29, 2022)
  • K201191 — ELEC-LED (February 7, 2022)
  • K192809 — Dental Handpiece (August 25, 2020)
  • K161500 — MEG-TORQ (February 22, 2017)

Other clearances for product code EBW

  • K251407 — Motor Handpiece and Control Unit (SDI10) (January 30, 2026)
  • K251701 — Star E900 Electric System (January 12, 2026)
  • K251811 — Motor and Apex Module (MaAM) (August 25, 2025)
  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)

FDA data resources