FDA.reportPublic FDA data

CDR

Primary DI
D764B10710231
Brand
CDR
Company
SIRONA DENTAL, INC.
Model
B1071023
Device description
PHOENIX HORIZONTAL BITEWING HOLDER SIZE 1 (25/PKG)
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
D764B10710231PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, reusableA device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
078613913
Device count
1
Kit
true
Sterilization required before use
true

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