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510(k) K192809

Dental Handpiece by Micro-Nx Co., Ltd. — Product Code EFA

K192809 is an FDA 510(k) premarket notification submitted by Micro-Nx Co., Ltd. for the device "Dental Handpiece". The FDA issued a decision of Substantially Equivalent on August 25, 2020. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, Dental), 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
August 25, 2020
Date Received
October 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Belt And/Or Gear Driven, 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)
  • K220577 — Dental Handpiece, Model CA160, CA160L, and CA500L (July 29, 2022)
  • K201191 — ELEC-LED (February 7, 2022)
  • K201192 — Impla-NX (Model: ISE-270M) (May 21, 2021)
  • K161500 — MEG-TORQ (February 22, 2017)

Other clearances for product code EFA

  • K163239 — SMARTmatic (March 17, 2017)
  • K143465 — MASTERmatic LUX (April 9, 2015)
  • K101172 — RDT3 HANDPIECE HEAD MODEL RDT3 (July 27, 2010)
  • K093894 — ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (March 3, 2010)
  • K092446 — INTRA LUX HEAD 3 LDSY (November 3, 2009)
  • K090055 — LOW & HIGH SPEED KIT (October 27, 2009)
  • K092412 — STRONG IMPLANT HANDPIECES (September 3, 2009)
  • K090676 — MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (May 22, 2009)
  • K070084 — MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (March 8, 2007)
  • K061701 — HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) (August 25, 2006)

FDA data resources