CARESTREAM DENTAL LLC

Address:3625 Cumberland Boulevard,Atlanta,GA,30339,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

Unit, Operative Dental (EIA) (6) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (NOF) (4)

Premarket Exempt

No Yes

Clear

CS 3600 - 60192155950032 Catalog Number : CPAE7600

Device Description : CS 3600 POSTERIOR TIP

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : No

Device Count : 1

CS 1200 - 60192155950438 Catalog Number : 9G5275

Device Description : CS1200 Handpiece

Device Class : 1

Duns Number: 019796106

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

CS 1500 - 60192156559807 Catalog Number : 6559801

Device Description : CS1500 INTRA ORAL CAMERA WIRELESS

Device Class : 1

Duns Number: 019796106

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

CS 1500 - 60192156559814 Catalog Number : 6559819

Device Description : CS1500 INTRA ORAL CAMERA WIRED USB

Device Class : 1

Duns Number: 019796106

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

CS 1500 - 60192156559852 Catalog Number : 6559850

Device Description : CS1500 HAND PIECE WIRELESS

Device Class : 1

Duns Number: 019796106

Premarket Exempt : No

Product Code : EIA

Prescription Use : No

Device Count : 1

CS 1200 - 60192156559999 Catalog Number : 6559991

Device Description : CS1200 INTRA ORAL CAMERA WIRED USB

Device Class : 1

Duns Number: 019796106

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

CS 1200 - 60192156560070 Catalog Number : 6560072

Device Description : CS1200 INTRA ORAL CAMERA AV

Device Class : 1

Duns Number: 019796106

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

CS 3600 - 60192156568748 Catalog Number : 6568745

Device Description : CS 3600 I/O 3D SCANNER

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

CS 3600 - 60192156577153 Catalog Number : 6577159

Device Description : CS3600 ACCESS I/O 3D SCANNER

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

CS 3600 - 60192156577894 Catalog Number : 6577894

Device Description : CS 3600 POSTERIOR TIP KIT

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : No

Device Count : 1

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