FDA.reportPublic FDA data

DENTRA III

Primary DI
60192155944833
Brand
DENTRA III
Company
CARESTREAM DENTAL LLC
Model
5944830
Catalog number
5944830
Device description
DENTRA III SIZE 1
Published
2023-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EAPUnit, X-Ray, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAPUnit, X-Ray, IntraoralDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60192155944833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6019215594483360192155944833

GMDN Terms#

Term, Definition table
TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

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
D0031000072190SchickDentsply International Inc.EAP2024-11-06
D0031000072200SchickDentsply International Inc.EAP2024-11-06
D0031000072210SchickDentsply International Inc.EAP2024-11-06
D0031000082860SchickDentsply International Inc.EAP2024-11-06
D0031000082900SchickDentsply International Inc.EAP2024-11-06
D0031000085860SchickDentsply International Inc.EAP2024-11-06
D0031000085870SchickDentsply International Inc.EAP2024-11-06
D0031000085880SchickDentsply International Inc.EAP2024-11-06
D0031000086240SchickDentsply International Inc.EAP2024-11-06
D0031000086250SchickDentsply International Inc.EAP2024-11-06
D0031000086260SchickDentsply International Inc.EAP2024-11-06
D0031000086270SchickDentsply International Inc.EAP2024-11-06
D0031000086280SchickDentsply International Inc.EAP2024-11-06
D0031000086290SchickDentsply International Inc.EAP2024-11-06
D0031000086300SchickDentsply International Inc.EAP2024-11-06
D0031000086310SchickDentsply International Inc.EAP2024-11-06
D0031000086320SchickDentsply International Inc.EAP2024-11-06
D0031000086330SchickDentsply International Inc.EAP2024-11-06
D0031000086340SchickDentsply International Inc.EAP2024-11-06
D0031000086350SchickDentsply International Inc.EAP2024-11-06
D0031000086360SchickDentsply International Inc.EAP2024-11-06
D0031000086370SchickDentsply International Inc.EAP2024-11-06
D0031000086380SchickDentsply International Inc.EAP2024-11-06
D0031000086390SchickDentsply International Inc.EAP2024-11-06
D0031000086400SchickDentsply International Inc.EAP2024-11-06
D0031000086410SchickDentsply International Inc.EAP2024-11-06
D0031000086510SchickDentsply International Inc.EAP2024-11-06
D0031000086520SchickDentsply International Inc.EAP2024-11-06
D0031000086530SchickDentsply International Inc.EAP2024-11-06
D0031000086540SchickDentsply International Inc.EAP2024-11-06