Not currently registered with FDA under this name

Kodent, Inc.

Anaheim, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2004 and 2004. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12004–2004
Markets registered in
22 registrations outside the US
Establishments
0—
2004: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 2 markets

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

All markets
United States: 1 clearancesArgentina: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantKodent, Inc.1 clearances2004–2004Below
ArgentinaANMATRegistration holderKODENT SA2—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 Kodent, Inc. as the applicant.

Decided510(k)DeviceDevice type
2 Aug 2004K041378BIO 60EJT Gold-Based Noble Metal Alloy

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.