FDA.reportPublic FDA data

Universal Holders

Primary DI
D764B10731071
Brand
Universal Holders
Company
SIRONA DENTAL, INC.
Model
B1073107
Device description
Universal Bitewing Holder - Red
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGZHolder, Film, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGZHolder, Film, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D764B10731071PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental x-ray film holder, single-useA device designed to stabilize a dental x-ray film intraorally during the taking of a dental x-ray. It is typically an adhesive-backed device designed to fold into a T-shape which adheres to the x-ray film and provides a tab that, when bitten down on, stabilizes the film adjacent to the teeth whilst the x-ray is being taken. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.659.5977imagingsupportus@dentsplysirona.com

Regulatory Flags#

DUNS number
078613913
Device count
1
Premarket exempt
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
10371347019633Advance Dental ProductsThe Atlanta Dental Supply CompanyEGZ2025-11-18
10304040192112CarinaHENRY SCHEIN, INC.EGZ2025-05-13
D00361765101XiosDentsply International Inc.EGZ2024-11-06
D00361765281XiosDentsply International Inc.EGZ2024-11-06
D00361765361XiosDentsply International Inc.EGZ2024-11-06
D00361765511XiosDentsply International Inc.EGZ2024-11-06
D003B10730511UniversalDentsply International Inc.EGZ2024-11-06
D003B10730521UniversalDentsply International Inc.EGZ2024-11-06
D003B10730531UniversalDentsply International Inc.EGZ2024-11-06
D003B10730541UniversalDentsply International Inc.EGZ2024-11-06
08717228440007DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440014DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440021DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440113DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440120DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440137DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440144DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440168DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440175DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440182DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440212DenBiteDuPhaMed B.V.EGZ2023-11-24
08717228440250CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440281CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440298CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440366CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440373CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440380CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440397CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440403CeflaDuPhaMed B.V.EGZ2023-11-23
08717228440410CeflaDuPhaMed B.V.EGZ2023-11-23