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510(k) K120659

HU-FRIEDY DENTAL CARTRIDGE SYRINGE by Hu-Friedy Mfg. Co., LLC — Product Code EJI

K120659 is an FDA 510(k) premarket notification submitted by Hu-Friedy Mfg. Co., LLC for the device "HU-FRIEDY DENTAL CARTRIDGE SYRINGE". The FDA issued a decision of Substantially Equivalent on November 6, 2012. The device falls under product code EJI (Syringe, Cartridge), a Class II device regulated under 21 CFR 872.6770. Hu-Friedy Mfg. Co., LLC has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2012
Date Received
March 5, 2012
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 Hu-Friedy Mfg. Co., LLC

  • K100401 — SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM (March 30, 2010)
  • K073369 — EI DOWNPAK BARRIER SLEEVES (February 27, 2008)
  • K070975 — SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES (June 21, 2007)
  • K053178 — SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS (February 1, 2006)
  • K012060 — MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT (July 27, 2001)
  • K953919 — DENTAL ULTRASONIC SCALER INSERTS (October 7, 1995)
  • K912473 — ACCU-PLACER TM KIT (July 24, 1991)
  • K844002 — HU-FRIEDY IMS CASSETTE SYSTEM (November 8, 1984)

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)
  • 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