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510(k) K925567

E 4000 DENTAL OPERATING CHAIR by Dentalez Group — Product Code KLC

K925567 is an FDA 510(k) premarket notification submitted by Dentalez Group for the device "E 4000 DENTAL OPERATING CHAIR". The FDA issued a decision of Substantially Equivalent on March 10, 1994. The device falls under product code KLC (Chair, Dental, With Operative Unit), a Class I device regulated under 21 CFR 872.6250. Dentalez Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1994
Date Received
November 3, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Dental, With Operative Unit
Device Class
Class I
Regulation Number
872.6250
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)
  • K960719 — STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE (March 28, 1996)
  • 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 KLC

  • K233921 — Luvis Chair (LC700C) (September 6, 2024)
  • K151987 — DCI Edge Dental Chair with Operative Unit (June 1, 2016)
  • K071353 — FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (December 14, 2007)
  • K971063 — OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (June 3, 1997)
  • K963209 — PROSTYLE COMPACT (October 24, 1996)
  • K942870 — ULTIMA 2 DENTAL CHAIR (February 27, 1995)
  • K940950 — KAVO SYSTEMATICA 1060 (December 29, 1994)
  • K923534 — PM2002 PROLINE (January 31, 1994)
  • K925119 — A-DEC 1040 CHAIR (January 31, 1994)
  • K925318 — A-DEC 2181 DUO UNIT (December 9, 1993)

FDA data resources