Dental Imaging Technologies Corporation

Address:450 Commerce Drive,Quakertown,PA,18951,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

System,x-ray,extraoral source,digital (MUH) (7) X-ray, tomography, computed, dental (OAS) (2) X-Ray, Tomography, Computed, Dental (OAS) (1)

Premarket Exempt

No Yes

Clear

Kavo 3D eXam i™ imaging system - EKAV083010000 Catalog Number : 08301000

Device Description : Dental CBCTDental CBCT

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex CB-500™ imaging system - EKAV083020000 Catalog Number : 08302000

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Gendex CB-500™ HD imaging system - EKAV083030000 Catalog Number : 08303000

Device Description : Dental CBCT

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

i-CAT 17-19™ imaging system - EKAV083040000 Catalog Number : 08304000

Device Description : Dental CBCTDental CBCT

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

i-CAT Precise™ imaging system - EKAV083050000 Catalog Number : 08305000

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

i-CAT FLX™ imaging system - EKAV083060000 Catalog Number : 08306000

Device Description : V17

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

i-CAT FLX™ imaging system - EKAV083063000 Catalog Number : 08306300

Device Description : V10

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

i-CAT FLX™ imaging system - EKAV083065000 Catalog Number : 08306500

Device Description : V8

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

i-CAT FLX MV™ imaging system - EKAV083070000 Catalog Number : 08307000

Device Description : Dental CBCTDental CBCT

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Kavo 3D eXam+™ imaging system - EKAV083080000 Catalog Number : 08308000

Device Class : 2

Duns Number: 800111106

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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