DEXIS LLC

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) (5) CAMERA, SURGICAL AND ACCESSORIES (KQM) (2) UNIT, OPERATIVE DENTAL (EIA) (2) Cover, barrier, protective (MMP) (1)

Premarket Exempt

No Yes

Clear

DEXIS Platinum™ intraoral sensor - EKAV082250710 Catalog Number : PLU5101S

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 - EKAV082250730 Catalog Number : PLU5102C

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 - EKAV082250740 Catalog Number : PLU5102S

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 - EKAV082251940 Catalog Number : PLU690

Device Description : Digital intraoral sensor

Device Class : 2

Duns Number: 019717844

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

DEXcam3™ intra-oral camera sheaths - EKAV082269210 Catalog Number : PLU795002

Device Description : 100 Count

Device Class :

Duns Number: 019717844

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 100

DEXcam3™ intraoral cameras - EKAV100713330 Catalog Number : PLU790

Device Description : Digital intraoral camera

Device Class : 1

Duns Number: 019717844

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

DEXcam3™ intra-oral camera sheaths - EKAV100713360 Catalog Number : PLU795003

Device Description : 500 Count

Device Class :

Duns Number: 019717844

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : Yes

Device Count : 500

DEXcam3™ intraoral cameras - EKAV100719690 Catalog Number : PLU791

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 - EKAV100730420 Catalog Number : PLU5101I

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 sheaths - EKAV100826680 Catalog Number : PLU975019

Device Description : 100 Count

Device Class :

Duns Number: 019717844

Premarket Exempt : No

Product Code : MMP

Prescription Use : Yes

Device Count : 100

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