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510(k) K982593

LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE by Dentalez Group — Product Code EFB

K982593 is an FDA 510(k) premarket notification submitted by Dentalez Group for the device "LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE". The FDA issued a decision of Substantially Equivalent on October 22, 1998. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Dentalez Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1998
Date Received
July 24, 1998
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)
  • K960719 — STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE (March 28, 1996)
  • K960507 — STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES (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)
  • K902402 — HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE (August 29, 1990)

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)

FDA data resources