Home / 510(k) Clearances / K100389

510(k) K100389

HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT by Handpiece Headquarters — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2010
Date Received
February 16, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Handpiece Headquarters

  • K243911 — HPR Cordless Hygiene Handpiece (December 20, 2024)
  • K233518 — BASE290 LED Curing Light (November 2, 2023)
  • K143183 — Maxima XTEND Handpiece Maintenance System (February 17, 2015)
  • K141125 — U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE (October 23, 2014)
  • K092053 — MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH (August 20, 2009)

Other clearances for product code EFB

  • K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES (January 12, 2026)
  • K251389 — High speed air turbine handpiece (January 12, 2026)
  • K242179 — Synea Fusion Handpieces (Intensiv & Profin) (February 28, 2025)
  • K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, (November 13, 2024)
  • K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dent (November 12, 2024)
  • K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing Sys (September 20, 2024)
  • K233122 — High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L, (April 30, 2024)
  • K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (April 25, 2024)
  • K220179 — High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Ai (September 22, 2023)
  • K232243 — EVO 700 series high speed handpiece (August 23, 2023)