FDA.reportPublic FDA data

CS 8100

Primary DI
60192155303043
Brand
CS 8100
Company
CARESTREAM DENTAL LLC
Model
CS 8100
Catalog number
5303045
Device description
CS 8100 110V 230V
Published
2018-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120975000CS 8100 CS 8100 ACCESSTrophy2012-06-22MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60192155303043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6019215530304360192155303043

GMDN Terms#

Term, Definition table
TermDefinition
Stationary extraoral dental x-ray system, digitalA diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed outside the mouth, the purpose being to visualize the entire mouth area showing teeth on both the upper and lower jaws. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
019796106
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60192155951237CS 9600TP FACE SCAN KIT FOR TP SUPREME 3D2026-05-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
D090101397120IXS S2 Kit, CT, US, FR-CADental Imaging Technologies CorporationMUH2026-05-12
D090101329460DEXIS IXS Size 1 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090101329470DEXIS IXS Size 2 Sensor - RDental Imaging Technologies CorporationMUH2026-04-01
D090800045720DEXIS Ti2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045730DEXIS IXS Size 1 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045740DEXIS IXS Size 1 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045750DEXIS IXS Size 2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045760DEXIS IXS Size 2 Sensor - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045770DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045780DEXIS IXS Size 2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800045790DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045810DEXIS IXS S2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045830DEXIS Ti2 Kit - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045840DEXIS Ti2 Kit - R - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045850IXS S1 Warranty Replacement - SDental Imaging Technologies CorporationMUH2026-04-01
D090800045860IXS S1 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045870IXS S2 Warranty NEW KitDental Imaging Technologies CorporationMUH2026-04-01
D090800045880IXS S2 Warranty Replacement KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049760DEXIS Ti2 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049770DEXIS IXS Size 1 Sensor - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049790DEXIS Ti2 Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049800DEXIS Ti2 Sensor & Acc. Kit - DDental Imaging Technologies CorporationMUH2026-04-01
D090800049810DEXIS IXS S1 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800049820DEXIS IXS Size 2 KitDental Imaging Technologies CorporationMUH2026-04-01
D090800457100DEXIS Ti2 Sensor - SDental Imaging Technologies CorporationMUH2026-04-01
08800000500164Cocoon SoloDEXCOWIN CO., LTD.MUH2026-03-31
D678J1205E0ScanX Duo TouchAIR TECHNIQUES, INC.MUH2026-03-27