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510(k) K113247

ANESTHESIA INJECTION TOOL SET by Ki Works Co., Ltd. — Product Code EJI

K113247 is an FDA 510(k) premarket notification submitted by Ki Works Co., Ltd. for the device "ANESTHESIA INJECTION TOOL SET". The FDA issued a decision of Substantially Equivalent on March 27, 2012. 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
March 27, 2012
Date Received
November 2, 2011
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

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  • K142414 — Miltex N-Tralig Intraligamentary Syringe (October 30, 2014)
  • K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE (November 6, 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