FONA SRL

FONA SRL

Address:VIA GALILEI 11,ASSAGO Milano,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

Unit, X-Ray, Extraoral With Timer (EHD) (6) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (4) System,X-Ray,Extraoral Source,Digital (MUH) (4) X-Ray, Tomography, Computed, Dental (OAS) (4)

Premarket Exempt

No

Clear

Vario DG - E31562802700 Catalog Number :

Device Description : Intraoral X-ray unit (70 kV, 3.5 mA), sensor not included

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

PantOs 16 xp - E31584682001000 Catalog Number :

Device Description : Analog Panoramic X-Ray Unit with 15x30 cm cassette, including patient positioning items

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : MQB, EHD, MUH

Prescription Use : Yes

Device Count : 1

PantOs DG xp - E31584682003000 Catalog Number :

Device Description : Digital Panoramic X-Ray Unit, including patient positioning items

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : EHD, MQB, MUH

Prescription Use : Yes

Device Count : 1

PantOs 16 xp Ceph - E31584682005000 Catalog Number :

Device Description : Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including pat Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : EHD, MQB, MUH

Prescription Use : Yes

Device Count : 1

PantOs 16 xp - E31584682012000 Catalog Number :

Device Description : Analog Panoramic X-Ray Unit with 24x30 cm cassette, including patient positioning items

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : MUH, MQB, EHD

Prescription Use : Yes

Device Count : 1

Stellaris 3D - E3158468600000 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Stellaris 3D Ceph - E3158468600002 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Stellaris 2D - E3158468600007 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

Stellaris 2D Ceph - E3158468600008 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

FONA XDC - E3159319001700 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

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