3DIEMME SRL

Address:Via Risorgimento 9,Cantu Como,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

System, Image Processing, Radiological (LLZ) (6) Accessories, Implant, Dental, Endosseous (NDP) (3) Non-Irrigation Endosseous Dental Implant Drill Bits (QRQ) (1)

Premarket Exempt

No Yes

Clear

3DIEMME RealGUIDE - 08050038830003 Catalog Number :

Device Description : Mobile version

Device Class : 2

Duns Number: 857172105

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

3DIEMME RealGUIDE - 08050038830010 Catalog Number :

Device Description : Implants planning

Device Class : 2

Duns Number: 857172105

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

3DIEMME RealGUIDE - 08050038830027 Catalog Number :

Device Description : Surgical guides modelling

Device Class : 2

Duns Number: 857172105

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

3DIEMME RealGUIDE - 08050038830034 Catalog Number :

Device Description : 3D diagnosis and communication module

Device Class : 2

Duns Number: 857172105

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

3DIEMME RealGUIDE - 08050038830041 Catalog Number :

Device Description : Prosthesis modelling (stand-alone)

Device Class : 2

Duns Number: 857172105

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

3DIEMME RealGUIDE - 08050038830058 Catalog Number :

Device Description : Full integrated planning, guide design and prosthesis modelling

Device Class : 2

Duns Number: 857172105

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Drill D2,4x6mm RealGUIDE Z3D Kit - 08050038830300 Catalog Number :

Device Class : 1

Duns Number: 857172105

Premarket Exempt : Yes

Product Code : QRQ

Prescription Use : No

Device Count : 1

RealGUIDE IMPLANT MOUNT - 08050038831093 Catalog Number :

Device Description : Implant mount (Zimmer Eztetic D3,1mm connection) - RealGUIDE Z3D Kit

Device Class : 1

Duns Number: 857172105

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

RealGUIDE IMPLANT MOUNT - 08050038831109 Catalog Number :

Device Description : Implant mount (Zimmer TSV D3,7/4,1mm connection) - RealGUIDE Z3D Kit

Device Class : 1

Duns Number: 857172105

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

RealGUIDE IMPLANT MOUNT - 08050038831116 Catalog Number :

Device Description : Implant mount (Zimmer TSV D4,7mm connection) - RealGUIDE Z3D Kit

Device Class : 1

Duns Number: 857172105

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

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