EU → North America 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 IIa602
Class IIb822
Class I11

Most frequent device types declared: BIPHASIC DENTAL IMPLANT, DENTAL DRILL, DENTAL DRIVER, DEPTH STOP, FINAL ABUTMENT.

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

Devices declared under this manufacturer

Showing 12 of 1 435 declared devices.

Catalogue references include 00384/Q-23, 3D-17032, 3P-00099SC, GD-767/2, INN-00542/1, INN-00604S.

European nomenclature codes declared: P01020180, P01020101, Z12110102, Q010207, L26, L80.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 435
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN1 435
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. B. & B. Dental S.r.l. was not found in either the U.S. or the Canadian register.

Notified body certificates

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

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