EU → US Device Access

Exotec Dentaire

FR-MF-000004026 · France · SENNECEY-LÈS-DIJON

Exotec Dentaire is registered in the European database on medical devices as a manufacturer, with 104 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa104

Most frequent device types declared: SEQUENCEUR RC TITANE CORPORIS, Foret et alesoir Corporis, Tenon et clavette RC calcinables et séquenceur Corporis, Séquenceur MF UDMA Corporis, SEQUENCEUR SP TITANE CORPORIS.

Among these devices, 64 are declared implantable, 16 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 EUDAMED104
Country of registrationFrance
⚠️ 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.

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