Biodenta Swiss AG

Address:Tramstrasse 16,Berneck Sankt Gallen,CH

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Accessories, Implant, Dental, Endosseous (NDP) (3) Abutment, Implant, Dental, Endosseous (NHA) (2)

Premarket Exempt

No Yes

Clear

Biodenta - 07640169736322 Catalog Number : CAD-UABHMU

Device Description : Universal Analog Compatible with BioHorizons Internal Mutli-Unit Abutment

Device Class : 1

Duns Number: 484609081

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Biodenta - 07640169736346 Catalog Number : CAD-SBATOS3545

Device Description : Scan Body with Screw Compatible with Astra Tech OsseoSpeed 3.5/4.0 IOS

Device Class : 1

Duns Number: 484609081

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Biodenta - 07640169736353 Catalog Number : CAD-SBATOS4550

Device Description : Scan Body with Screw Compatible with Astra Tech OsseoSpeed 4.5/5.0

Device Class : 1

Duns Number: 484609081

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

Biodenta - 07640169739910 Catalog Number :

Device Description : Biodenta Customized Abutment - Titanium

Device Class : 2

Duns Number: 484609081

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Biodenta - 07640169739927 Catalog Number :

Device Description : Biodenta Customized Abutment - Hybrid

Device Class : 2

Duns Number: 484609081

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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