FDA.reportPublic FDA data

CS 9600

Primary DI
60192155951237
Brand
CS 9600
Company
CARESTREAM DENTAL LLC
Model
TP FACE SCAN KIT FOR TP SUPREME 3D
Device description
TP FACE SCAN KIT FOR TP SUPREME 3D (CS 9600)
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60192155951237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6019215595123760192155951237

GMDN Terms#

Term, Definition table
TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., helmet, frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine typically during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.

Regulatory Flags#

DUNS number
019796106
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60192155951244CS 9600ADVANCED RADIOLOGY KIT FOR CS 96002026-05-15
60192155008047RVG 6500RVG 6500CIC422018-01-15
60192155008054RVG 6500RVG 6500CIC432018-01-15
60192155008061RVG 6500RVG 6500CIC442018-01-15
60192155319570Dental Imaging SoftwareDental Imaging Software53195792018-01-15
60192155319686CS 9300CS 930053196862018-01-15
60192155319693CS 9300CCS 9300C53196942018-01-15
60192155319716CS 9300 SelectCS 9300 Select53197102018-01-15
60192155319723CS 9300CS 930053197282018-01-15
60192155319730CS 9300CCS 9300C53197362018-01-15
60192155319747CS 9300 SelectCS 9300 Select53197442018-01-15
60192155950438CS 1200CS 12009G52752019-03-01
60192156559807CS 1500CS 150065598012019-03-01
60192156559814CS 1500CS 150065598192019-03-01
60192156559852CS 1500CS 150065598502019-03-01
60192156559999CS 1200CS 120065599912019-02-15
60192156560070CS 1200CS 120065600722019-03-01
60192156851635CS Orthodontic Imaging SoftwareCS Orthodontic Imaging Software10432722018-01-15
60192156851642CS Orthodontic Imaging SoftwareCS Orthodontic Imaging Software17468332018-01-15
60192156851659CS OMS Imaging SoftwareCS OMS Imaging Software15469772018-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
60192155951244CS 9600CARESTREAM DENTAL LLCOAS2026-05-15
E27668234830Primevision 3DSIRONA Dental Systems GmbHOAS2026-04-30
D804W1203005DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203005FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203010DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203015FLDRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
D804W1203020DRT0X-MIND optima 3DDE GÖTZEN SRLOAS2026-03-23
08033837934981myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837935001myrayCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936091NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936176CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
08033837936411CastelliniCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
E27668234260Primevision 3DSIRONA Dental Systems GmbHOAS2026-02-13
00990010312418DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312562DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312579DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312586DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312593DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312609DURAYBeyes Dental Canada IncOAS2025-12-15
08800003027026RAYSCANRay Co., LtdOAS2025-12-01
08809244060335GenorayGENORAY CO., LTD.OAS2025-12-01
08809244060472GenorayGENORAY CO., LTD.OAS2025-12-01
06974566270167FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566270181FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271294FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566270174FUSSENFussen Technology Co., Ltd.OAS2025-11-21
08800016401974Green X 21VATECH CO., LTD.OAS2025-11-12