RHEIN 83 SRL

Address:VIA EMILIO ZAGO 10abc,BOLOGNA Emilia-Romagna,IT

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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) Attachment, Precision, All (EGG) (2)

Premarket Exempt

No Yes

Clear

OT EQUATOR - D821OTEQUATOR130LEG477 Catalog Number :

Device Description : The OT Equator is designed as an endosseous dental implant retentive component u The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.

Device Class : 2

Duns Number: 439240722

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

OT EQUATOR TITANIUM ABUTMENT - D821OTEQUATOR30CV576 Catalog Number :

Device Class : 2

Duns Number: 439240722

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

DENTAL EQUIPMENTS - D821SBE0 Catalog Number : SBE

Device Description : DISPOSABLE device used to provide retention of a removable prosthesis anchored o DISPOSABLE device used to provide retention of a removable prosthesis anchored on metal hemi-spheres fixed in the mouth

Device Class : 1

Duns Number: 439240722

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

DENTAL EQUIPMENTS - D821SBE100 Catalog Number : SBE-100

Device Description : DISPOSABLE medical device. Smart Box Titanium housing for the caps

Device Class : 1

Duns Number: 439240722

Premarket Exempt : Yes

Product Code : EGG

Prescription Use : Yes

Device Count : 1

OT EQUATOR-OT BRIDGE - D821SBE500 Catalog Number : SBE-500

Device Class : 1

Duns Number: 439240722

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

OT EQUATOR-OT BRIDGE - D821SFE2ER0 Catalog Number : SFE2ER

Device Class : 1

Duns Number: 439240722

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

OT EQUATOR-OT BRIDGE - D821VE057 Catalog Number : VE057

Device Class : 1

Duns Number: 439240722

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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