FDA.reportPublic FDA data

FONA CDR DICOM

Primary DI
D764B10351060
Brand
FONA CDR DICOM
Company
SIRONA DENTAL, INC.
Model
B1035106
Device description
FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K933455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K933455000COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.1994-01-31EAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D764B10351060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(877) 724-4254customerserviceny@sirona.com

Regulatory Flags#

DUNS number
078613913
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7641000087211Schick331000087212022-03-23
D764B10742011AimRight HolderB10742012022-12-07
D764B10741041AimRight HolderB10741042022-12-07
D7641000086661Schick AE1000086662022-03-23
D7641000053241AimRight1000053242022-12-07
D7641000053251AimRight1000053252022-12-07
D7641000053301AimRight1000053302022-12-07
D7641000053311AimRight1000053312022-12-07
D7641000053321AimRight1000053322022-12-07
D7641000053331AimRight1000053332022-12-07
D7641000053341AimRight1000053342022-12-07
D7641000053451AimRight1000053452022-12-07
D764B02100001Intraoral Sensor Holders Arms and Rings B02100002022-12-07
D764B10730621Universal HoldersB10730622022-12-07
D764B10731001Intraoral Sensor Holder Arms and RingsB10731002022-12-07
D764B10731011Universal HoldersB10731012022-12-07
D764B10731021Universal HoldersB10731022022-12-07
D764B10731031Universal HoldersB10731032022-12-07
D764B10731041Universal HoldersB10731042022-12-07
D764B10731061Universal HoldersB10731062022-12-07

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