Home / 510(k) Clearances / K033381

510(k) K033381

DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL by Discus Dental, Inc. — Product Code MED

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2004
Date Received
October 22, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilant, Medical Devices
Device Class
Class II
Regulation Number
880.6885
Review Panel
HO
Submission Type

Other clearances by Discus Dental, Inc.

  • K102639 — SL3 (December 1, 2010)
  • K101612 — ZEN CORDLESS PROPHY SYSTEM (June 30, 2010)
  • K101215 — NUANCE (May 12, 2010)
  • K093208 — SIMPLISEAL (February 12, 2010)
  • K092417 — INSIGHT ULTRASONIC INSERTS (December 11, 2009)
  • K073518 — FLASHLITE REBEL* (December 20, 2007)
  • K062176 — RELIEF ACP ORAL CARE GEL (January 10, 2007)
  • K052090 — SPLASH! IMPRESSION MATERIAL DEVICE (August 5, 2005)
  • K051776 — PROTEGE ULTRASONIC INSERT (July 13, 2005)
  • K033785 — PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE (June 18, 2004)

Other clearances for product code MED

  • K232914 — SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liq (October 3, 2023)
  • K230582 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 (March 28, 2023)
  • K222615 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 28, 2022)
  • K211607 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (September 7, 2021)
  • K210737 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (May 12, 2021)
  • K192929 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chem (December 10, 2019)
  • K191343 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 (September 5, 2019)
  • K190104 — SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chem (March 22, 2019)
  • K182827 — SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 (January 31, 2019)
  • K180342 — SYSTEM 1E Liquid Chemical Sterilant Processing System (April 4, 2018)