SIRONA DENTAL, INC.

SIRONA DENTAL, INC.

Address:30-30 47TH AVE., Suite 500,Long Island City,NY,11101,US

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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

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (10) Unit, X-Ray, Extraoral With Timer (EHD) (10)

Premarket Exempt

No

Clear

FONA STELLARIS - D7641000053911 Catalog Number :

Device Description : FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000053921 Catalog Number :

Device Description : FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000053931 Catalog Number :

Device Description : FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000054101 Catalog Number :

Device Description : FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000054111 Catalog Number :

Device Description : FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000054121 Catalog Number :

Device Description : FONA STELLARIS S1 SENSOR SHIP KIT, .9M/3FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000054181 Catalog Number :

Device Description : FONA STELLARIS S0 SENSOR SHIP KIT, 1.8M/6FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000054191 Catalog Number :

Device Description : FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000054201 Catalog Number :

Device Description : FONA STELLARIS S0 SENSOR SHIP KIT, .9M/3FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : EHD, MQB

Prescription Use : Yes

Device Count : 1

FONA STELLARIS - D7641000055651 Catalog Number :

Device Description : FONA STELLARIS S2 SENSOR BASIC KIT, 1.8M/6FT

Device Class : 2

Duns Number: 078613913

Premarket Exempt : No

Product Code : MQB, EHD

Prescription Use : Yes

Device Count : 1

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