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510(k) K960719

STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE by Dentalez Group — Product Code EFA

K960719 is an FDA 510(k) premarket notification submitted by Dentalez Group for the device "STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code EFA (Handpiece, Belt And/Or Gear Driven, 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
March 28, 1996
Date Received
February 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Belt And/Or Gear Driven, 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)
  • K960260 — STAR TITAN SERIES MOTORS & ATTACHMENTS (March 28, 1996)
  • K960507 — STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES (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 EFA

  • K192809 — Dental Handpiece (August 25, 2020)
  • K163239 — SMARTmatic (March 17, 2017)
  • K143465 — MASTERmatic LUX (April 9, 2015)
  • K101172 — RDT3 HANDPIECE HEAD MODEL RDT3 (July 27, 2010)
  • K093894 — ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (March 3, 2010)
  • K092446 — INTRA LUX HEAD 3 LDSY (November 3, 2009)
  • K090055 — LOW & HIGH SPEED KIT (October 27, 2009)
  • K092412 — STRONG IMPLANT HANDPIECES (September 3, 2009)
  • K090676 — MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (May 22, 2009)
  • K070084 — MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (March 8, 2007)

FDA data resources