Not currently registered with FDA under this name

Tedequim Srl

Córdoba, Argentina. Named as applicant on 1 dental 510(k) clearance between 2024 and 2024. No establishment is registered with FDA under this exact name today.

1 clearance in five years
Device types listed
0
Brands and models
0
510(k) clearances
12024–2024
Markets registered in
21 registrations outside the US
Establishments
0—
2024: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Tedequim Srl as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesPeru: 1 registrations
RegisteredHome: ArgentinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantTedequim Srl1 clearances2024–2024Below
PeruDIGEMIDManufacturerTEDEQUIM S.R.L.12025–2025Pure 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 Tedequim Srl as the applicant.

Decided510(k)DeviceDevice type
16 May 2024K240059FAgamin®PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish

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.