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) (3) System, X-Ray, Extraoral Source, Digital (MUH) (3) System, Image Processing, Radiological (LLZ) (2) X-Ray, Tomography, Computed, Dental (OAS) (2) Analyzer, Medical Image (MYN) (1) Orthodontic Software (PNN) (1)

Premarket Exempt

No Yes

Clear

CS 7600 - 60192155942730 Catalog Number : 5942735

Device Description : CS 7600 IMAGING PLATE SYSTEM

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : MUH

Prescription Use : Yes

Device Count : 1

Logicon Caries Detector - 60192155942754 Catalog Number : 5942750

Device Description : CSD LOGICON CARIES DETECTOR

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : MYN

Prescription Use : No

Device Count : 1

CS Imaging Suite - 60192155943010 Catalog Number : 5943014

Device Description : CS IMAGING CLIENT SERVER SUITE

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

CS 3800 Wireless - 60192155943065 Catalog Number : 5943063

Device Description : CS 3800 3D I/O SCANNER WIRELESS

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

CS 8200 3D - 60192155943218 Catalog Number : 5943212

Device Description : CS 8200 3D

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : MUH, OAS

Prescription Use : Yes

Device Count : 1

SCAN CEPH - 60192155943232 Catalog Number : 5943238

Device Description : SCAN CEPH FOR CS 8200 3D

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : MUH, OAS

Prescription Use : Yes

Device Count : 1

CS 3800 Wired - 60192155943720 Catalog Number : 5943725

Device Description : CS 3800 3D I/O SCANNER WIRED

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : No

Device Count : 1

CS Model+ - 60192155944482 Catalog Number : 5944483

Device Description : LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Swissmeda powered by Carestream Dental - 60192155944543 Catalog Number : 5944541

Device Description : Swissmeda powered by Carestream Dental

Device Class : 2

Duns Number: 019796106

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

CS 3600 - 60192155950025 Catalog Number : CPAF7000

Device Description : CS 3600 ACCESS HANDPIECE

Device Class : 2

Duns Number: 019796106

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : No

Device Count : 1

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