Manufacturer registered with FDA

ADM, a.s.

Brno, Czechia. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9077377Manufacturer

Device types listed: 1
Brands and models: 17
510(k) clearances: 11995–1995
Markets registered in: 314 registrations outside the US
Establishments: 1Czechia

510(k) clearances per year, 1990–2026

Registered in 3 markets

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

All markets

RegisteredHome: CzechiaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	ADM, a.s.	1 clearances	1995–1995	Below
European Union	EUDAMED	Registration holder	ADM, a.s.	13	—	Pure Global AI
Taiwan	TFDA	Manufacturer	ADM, A.S.	1	2013–2013	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

Devices listed with FDA

What ADM, a.s. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	DENTAPREGDentapreg BRAIDDentapreg BUNDLEDentapreg INTRODentapreg MESHDentapreg MESH Economy PackDentapreg PFMDentapreg PFUDentapreg PINPostDentapreg SFM 7 more Dentapreg SFUDentapreg STARTER KITDentapreg UFMDentapreg VEILFibrafill CUBEFibrafill DENTINFibrafill FLOW	2005

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names ADM, a.s. as the applicant.

Decided	510(k)	Device	Device type
10 Aug 1995	K952353	EZ-COMP	EBF Resin Tooth Shade Material

Registered establishments

Establishment	Location	What it does
ADM, a.s.FDA reg. 3005347791	Brno Mesto Brno, Czechia	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9077377). 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.