EU → US Device Access

B. & B. Dental S.r.l.

IT-MF-000028342 · Italy · San Pietro in Casale

B. & B. Dental S.r.l. is registered in the European database on medical devices as a manufacturer, with 1 435 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb822
Class IIa602
Class I11

Most frequent device types declared: FINAL ABUTMENT, DENTAL DRILL, BIPHASIC DENTAL IMPLANT, MONOPHASIC DENTAL IMPLANT, MINI DENTAL IMPLANT.

Among these devices, 507 are declared sterile, 833 implantable.

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 EUDAMED1 435
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
ITI 2486145 1supplemented2029-07-31
ITH 2486145 1supplemented2029-07-31
CVD0021230226supplemented2028-11-27
CSQ0015230226supplemented2028-11-27

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