Home / 510(k) Clearances / K983105

510(k) K983105

CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 by Dentsply Midwest — Product Code EJI

K983105 is an FDA 510(k) premarket notification submitted by Dentsply Midwest for the device "CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01". The FDA issued a decision of Substantially Equivalent on March 8, 1999. 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 8, 1999
Date Received
September 4, 1998
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 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