DEXIS LLC

Address:10308 Bailey Road,Cornelius,NC,28031,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) (3) UNIT, OPERATIVE DENTAL (EIA) (3) CAMERA, SURGICAL AND ACCESSORIES (KQM) (1) System, image processing, radiological (LLZ) (1)

Premarket Exempt

Yes No

Clear

DEXcam4™ Intra-oral camera sheaths - EKAV101149940 Catalog Number : PLU7611S

Device Description : 500 Count

Device Class :

Duns Number: 019717844

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 500

DEXcam4™ Intra-oral camera - EKAV101149960 Catalog Number : PLU7610K

Device Description : Digital intraoral camera

Device Class : 1

Duns Number: 019717844

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

DEXIS Platinum™ intraoral sensor - EKAV101184170 Catalog Number : PLU5109S

Device Description : Digital intraoral sensor

Device Class : 2

Duns Number: 019717844

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

DEXIS Platinum™ intraoral sensor - EKAV101184180 Catalog Number : PLU5109C

Device Description : Digital intraoral sensor

Device Class : 2

Duns Number: 019717844

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

DEXIS Platinum™ intraoral sensor - EKAV101184190 Catalog Number : PLU5109I

Device Description : Digital intraoral sensor

Device Class : 2

Duns Number: 019717844

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

DEXIS™ Software - EKAV101244750 Catalog Number : 1.012.4475

Device Description : Software

Device Class : 2

Duns Number: 019717844

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

DEXcam3™ intraoral cameras - EKAV101289030 Catalog Number : 1.012.8903

Device Description : Digital intraoral camera

Device Class : 1

Duns Number: 019717844

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

DEXcam3™ intraoral cameras - EKAV101289070 Catalog Number : 1.012.8907

Device Description : Digital intraoral camera

Device Class : 1

Duns Number: 019717844

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

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