Home / 510(k) Clearances / K896361

510(k) K896361

HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE by Dentalez Group — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1990
Date Received
November 6, 1989
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 Dentalez Group

  • K030133 — SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA (April 29, 2003)
  • K021378 — PORTABLE HDX INTRAORAL X-RAY (June 7, 2002)
  • K990844 — STARDENTAL AXCS STERILE WATER SYSTEM (May 28, 1999)
  • K983574 — STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS (January 8, 1999)
  • K982593 — LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SE (October 22, 1998)
  • K960507 — STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES (March 28, 1996)
  • K960719 — STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE (March 28, 1996)
  • K960260 — STAR TITAN SERIES MOTORS & ATTACHMENTS (March 28, 1996)
  • K925567 — E 4000 DENTAL OPERATING CHAIR (March 10, 1994)
  • K931093 — QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE (January 21, 1994)

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)