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510(k) K022959

SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 by MDC Research , Ltd. — Product Code EJI

K022959 is an FDA 510(k) premarket notification submitted by MDC Research , Ltd. for the device "SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1". The FDA issued a decision of Substantially Equivalent on February 5, 2003. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. MDC Research , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2003
Date Received
September 6, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

Other clearances by MDC Research , Ltd.

  • K973012 — MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM (November 5, 1997)
  • K960013 — MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM (February 13, 1996)

Other clearances for product code EJI

  • K171254 — LeEject 2 Dental Syringe and Needle System (November 16, 2017)
  • K142414 — Miltex N-Tralig Intraligamentary Syringe (October 30, 2014)
  • K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE (November 6, 2012)
  • K113247 — ANESTHESIA INJECTION TOOL SET (March 27, 2012)
  • K082249 — MORPHEUS (December 31, 2009)
  • K092943 — ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE (December 11, 2009)
  • K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRAT (March 9, 2009)
  • K081694 — DENJECTOR (September 12, 2008)
  • K061904 — COMPUDENT STA (August 8, 2006)
  • K043322 — MIRAMATIC SAFE SYRINGE SYSTEM (July 21, 2005)

FDA data resources