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510(k) K171254

LeEject 2 Dental Syringe and Needle System by Advanced Technology and Capital, Inc. — Product Code EJI

K171254 is an FDA 510(k) premarket notification submitted by Advanced Technology and Capital, Inc. for the device "LeEject 2 Dental Syringe and Needle System". The FDA issued a decision of Substantially Equivalent on November 16, 2017. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2017
Date Received
April 28, 2017
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 for product code EJI

  • 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)
  • K040671 — EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING (December 14, 2004)

FDA data resources