Dental Device Guide
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Not currently registered with FDA under this name

Koei International, Inc.

Mchenry, IL, United States. Named as applicant on 1 dental 510(k) clearance between 1981 and 1981. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11981–1981
Markets registered in
1United States
Establishments
0—
1981: 119801990200020102020

510(k) clearances per year, 1980–2026

510(k) clearances

Clearances on which FDA names Koei International, Inc. as the applicant.

Decided510(k)DeviceDevice type
27 May 1981K811175RECOH ROOT CANAL IRRIGATOREFS Oral Irrigation Unit

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.