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510(k) K002168

ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE by Ronvig Instruments, Ltd. — Product Code EJI

K002168 is an FDA 510(k) premarket notification submitted by Ronvig Instruments, Ltd. for the device "ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE". The FDA issued a decision of Substantially Equivalent on October 13, 2000. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Ronvig Instruments, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2000
Date Received
July 17, 2000
Clearance Type
Abbreviated
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 Ronvig Instruments, Ltd.

  • K904279 — PAROJECT ANESTHETIC SYRINGE (December 7, 1990)

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