EU → US Device Access

DENTAL WORLD S.R.L.

IT-MF-000019581 · Italy · Molfetta (BA)

DENTAL WORLD S.R.L. is registered in the European database on medical devices as a manufacturer, with 898 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa898

Most frequent device types declared: Thermoformable plates, Orthodontic Instruments, Disposable surgical masks, Ortho Box, Ortho Bite.

Among these devices, 4 are declared sterile, 23 reusable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED898
Country of registrationItaly
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
IT332137supplemented2029-04-18

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