Home / 510(k) Clearances / K022119

510(k) K022119

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE by Electro Medical Systems SA — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2002
Date Received
July 1, 2002
Clearance Type
Special
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 Electro Medical Systems SA

  • K022328 — EMS PIEZON MASTER 600 (August 13, 2002)
  • K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (August 24, 2001)
  • K002484 — EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (October 4, 2000)
  • K991857 — AIRFLOW HANDY (October 7, 1999)
  • K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE (July 27, 1999)
  • K965203 — RADX SYSTEM (March 17, 1997)
  • K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER (February 13, 1997)
  • K964111 — LITHOVAC SUCTION/ASPIRATION PROBE (December 16, 1996)
  • K953026 — MINIPIEZON (August 28, 1995)
  • K951531 — SWISS LITHOCLAST LITHOTRIPTER (August 24, 1995)

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)