Not currently registered with FDA under this name

Dentsply Midwest

Des Plaines, IL, United States. Named as applicant on 1 dental 510(k) clearance between 1999 and 1999. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11999–1999
Markets registered in: 23 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Dentsply Midwest as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Dentsply Midwest	1 clearances	1999–1999	Below
South Korea	MFDS	Manufacturer	DENTSPLY Midwest	3	1999–2001	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Dentsply Midwest as the applicant.

Decided	510(k)	Device	Device type
8 Mar 1999	K983105	CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01	EJI Cartridge Syringe

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.