CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01— 510(k) K983105

Name: FDA 510(k) clearance K983105
Creator: U.S. Food and Drug Administration
Published: 1999-03-08

Substantially Equivalent

Dentsply Midwest

FDA 510(k) clearance K983105 for CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01, Substantially Equivalent on 1999-03-08. Applicant: Dentsply Midwest. Device class: 2.

Clearance details

Applicant: Dentsply Midwest
Product code: Code EJI
Device class: Class 2
Regulation: 21 CFR 872.6770
Advisory panel: Dental
Date received: 1998-09-04
Decision date: 1999-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJI

view all

K171254 — LeEject 2 Dental Syringe and Needle System2017-11-16
K142414 — Miltex N-Tralig Intraligamentary Syringe2014-10-30
K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE2012-11-06
K113247 — ANESTHESIA INJECTION TOOL SET2012-03-27
K082249 — MORPHEUS2009-12-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.