Home / 510(k) Clearances / K990844

510(k) K990844

STARDENTAL AXCS STERILE WATER SYSTEM by Dentalez Group — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1999
Date Received
March 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
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)
  • 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)
  • K902402 — HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE (August 29, 1990)

Other clearances for product code EIA

  • K251626 — Midmark Dental Delivery System (November 3, 2025)
  • K251491 — K5 Cart, K5 Mount, K5 Swing (July 17, 2025)
  • K243130 — Integral Dental Unit (June 27, 2025)
  • K242611 — Integral Dental Units (May 27, 2025)
  • K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (February 19, 2025)
  • K242404 — BDC Dental Unit (February 7, 2025)
  • K231297 — Firstar Dental Unit (January 27, 2025)
  • K233805 — K5 (September 3, 2024)
  • K240754 — N2 (March 21, 2024)
  • K231845 — Dental unit Model: Mare (February 28, 2024)