Home / 510(k) Clearances / K152146

510(k) K152146

High Speed Handpieces and Accessories by Codent Technical Industry Co., Ltd. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2015
Date Received
August 3, 2015
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 Codent Technical Industry Co., Ltd.

  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K150798 — Codent Low Speed Dental Handpieces and Accessories (April 24, 2015)
  • K133069 — CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES (October 24, 2014)
  • K033213 — CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS (February 6, 2004)

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)