Not currently registered with FDA under this name

Katecho, Inc.

Des Moines, IA, United States. Named as applicant on 1 dental 510(k) clearance between 1984 and 1984. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11984–1984
Markets registered in
422 registrations outside the US
Establishments
0—
1984: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 4 markets

Where regulators' registries name Katecho, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 18 registrationsColombia: 3 registrationsAustralia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantKatecho, Inc.1 clearances1984–1984Below
South KoreaMFDSManufacturerKatecho, Inc.Katecho, Inc · Katecho, INC · +2182003–2020Pure Global AI
ColombiaINVIMAManufacturerKATECHO INCKATECHO LLC3—Pure Global AI
AustraliaTGAManufacturerKatecho Inc12006–2006Pure 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 Katecho, Inc. as the applicant.

Decided510(k)DeviceDevice type
30 Nov 1984K843557K-APATITE 20-40 MESH K-APATITE 40-60ELE Subperiosteal Implant

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.