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510(k) K040671

EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES by Anthogyr — Product Code EJI

K040671 is an FDA 510(k) premarket notification submitted by Anthogyr for the device "EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES". The FDA issued a decision of Substantially Equivalent on December 14, 2004. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Anthogyr has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2004
Date Received
March 15, 2004
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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  • K230680 — Anthogyr Surgical Cassettes (July 11, 2023)
  • K161177 — Axiom PX (June 15, 2017)
  • K160730 — Instrument kits (April 27, 2017)
  • K141450 — AXIOM 2.8 (September 17, 2014)
  • K131066 — AXIOM REG (February 21, 2014)
  • K111532 — MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE (October 7, 2011)
  • K102241 — ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT (March 23, 2011)

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