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510(k) K081694

DENJECTOR by Dxm Co., Ltd. — Product Code EJI

K081694 is an FDA 510(k) premarket notification submitted by Dxm Co., Ltd. for the device "DENJECTOR". The FDA issued a decision of Substantially Equivalent on September 12, 2008. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Dxm Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2008
Date Received
June 17, 2008
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 Dxm Co., Ltd.

  • K191221 — Cybird LED Curing Light (January 10, 2020)
  • K173876 — Cybird LED Curing Light (January 24, 2018)
  • K121093 — D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 (November 27, 2012)
  • K042703 — CYBIRD LED CURING LIGHT (October 12, 2004)
  • K040116 — HAWK INTRAORAL CAMERA AND ACCESSORIES (April 20, 2004)

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)
  • 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