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

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (NOF) (4) X-Ray, Tomography, Computed, Dental (OAS) (4) System, X-Ray, Extraoral Source, Digital (MUH) (3) Orthodontic Software (PNN) (1)

Premarket Exempt

No Yes

Clear

Trophypan Supreme 3D - 60192155501548 Catalog Number : 5501549

Device Description : Trophypan Supreme 3D

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

CS 3700 - 60192155941306 Catalog Number : 5941307

Device Description : CS 3700 3D I/O SCANNER ARCTIC WHITE

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

CS 8100 3D - 60192155942129 Catalog Number : 5942123

Device Description : CS 8100 3D Select

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

CS 8100SC 3D - 60192155942136 Catalog Number : 5942131

Device Description : CS 8100SC 3D Select

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

CS 3600 - 60192155942143 Catalog Number : 5942149

Device Description : 3D I/O SCANNER, CS 3600 SDC

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

CS 3600 - 60192155942341 Catalog Number : 5942347

Device Description : CS 3600 I/O SCANNER W/CS SCANFLOW

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

SCAN CEPH - 60192155942396 Catalog Number : 5942396

Device Description : SCAN CEPH FOR CS 9600

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : OAS

Prescription Use : Yes

Device Count : 1

CS 3700 - 60192155942662 Catalog Number : 5942669

Device Description : CS 3700 3D I/O SCANNER CARBON GREY

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : No

Device Count : 1

CS Model+ - 60192155942716 Catalog Number : 5942719

Device Description : CS MODEL+

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

CS 7200 - 60192155942723 Catalog Number : 5942727

Device Description : CS 7200 IMAGING PLATE SYSTEM

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : MUH

Prescription Use : Yes

Device Count : 1

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