510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983105Substantially Equivalent

Ccs; Computer Controlled Syringe, Model #Ccs-100, Ccs; Cartridge Holder (Replacements), Model # Ccs-100-01

Dentsply Midwest, Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983105 is the FDA 510(k) clearance record for CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01, a class II device, cleared for Dentsply Midwest on under FDA product code EJI (Syringe, Cartridge). FDA records list one 510(k) clearance for Dentsply Midwest. As of , FDA records show no recalls naming K983105.

Clearance record

Decision date
Received
(185 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Dentsply Midwest 901 W. Oakton St., Des Plaines IL
510(k) summary
Summary
Third party review
No

Clearances, product code EJI

Trailing 12 months

FDA records hold no clearances under product code EJI in the trailing twelve months.

FDA records show no clearances under product code EJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260