Not currently registered with FDA under this name

Protomed, Inc.

Westminster, CO, United States. Named as applicant on 1 dental 510(k) clearance between 2020 and 2020. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12020–2020
Markets registered in: 35 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 3 markets

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

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Protomed, Inc.	1 clearances	2020–2020	Below
Saudi Arabia	SFDA	Manufacturer	Protomed SA	3	—	Pure Global AI
European Union	EUDAMED	Manufacturer	PROTOMED SA	2	—	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 Protomed, Inc. as the applicant.

Decided	510(k)	Device	Device type
4 Nov 2020	K193499	DigiGuide System	DZJ Manual Wire Driver and Bone Drill

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.