Not currently registered with FDA under this name

Madegom

Chile, Chile. Named as applicant on 1 dental 510(k) clearance between 1989 and 1989. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11989–1989
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 2 markets

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

All markets

RegisteredHome: ChileOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Madegom	1 clearances	1989–1989	Below
Peru	DIGEMID	Manufacturer	MADEGOM S.A.	1	2014–2014	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 Madegom as the applicant.

Decided	510(k)	Device	Device type
21 Aug 1989	K894120	MADEGOM LTDA. DENTAL DAM	EIE Rubber Dam

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.