FDA.reportPublic FDA data

AimRight

Primary DI
D7641000053341
Brand
AimRight
Company
SIRONA DENTAL, INC.
Model
100005334
Device description
AimRight Aiming Ring, Red 1 PC
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHAAligner, Beam, X-Ray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHAAligner, Beam, X-RayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7641000053341PrimaryHIBCC0

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

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
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
D764B10731071Universal HoldersB10731072022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D003B01200001SchickDentsply International Inc.EHA2024-11-06
D003B01210001SchickDentsply International Inc.EHA2024-11-06
D003B10731001UniversalDentsply International Inc.EHA2024-11-06
D003B01200000SchickDentsply International Inc.EHA2024-11-06
D003B01210000SchickDentsply International Inc.EHA2024-11-06
D003B01220001SchickDentsply International Inc.EHA2024-11-06
D003B10731000UniversalDentsply International Inc.EHA2024-11-06
D003B10731101AimRightDentsply International Inc.EHA2024-11-06
D003B24041001SchickDentsply International Inc.EHA2024-11-06
D003B24042001SchickDentsply International Inc.EHA2024-11-06
D764B02100001Intraoral Sensor Holders Arms and Rings SIRONA DENTAL, INC.EHA2022-12-07
D764B10731001Intraoral Sensor Holder Arms and RingsSIRONA DENTAL, INC.EHA2022-12-07
D764B10740501AimRight HolderSIRONA DENTAL, INC.EHA2022-12-07
D090082251290Endodontic Bar - Alignment BarDental Imaging Technologies CorporationEHA2022-12-06
D090086000360Bar, Alignment, Bitewing, DEXISDental Imaging Technologies CorporationEHA2022-12-06
D090086000370Bar, Alignment, UniversalDental Imaging Technologies CorporationEHA2022-12-06
D090100815220Bar, Alignment, BitewingDental Imaging Technologies CorporationEHA2022-12-06
D090100815230Bar, Alignment, UniversalDental Imaging Technologies CorporationEHA2022-12-06
D090100815240Bar, Alignment, EndodonticDental Imaging Technologies CorporationEHA2022-12-06
D090101114500Bar, Alignment, Bitewing, ShortDental Imaging Technologies CorporationEHA2022-12-06
D090101114510Bar, Alignment, Universal, ShortDental Imaging Technologies CorporationEHA2022-12-06
D090101115710Bar, Alignment, Endodontic, ShortDental Imaging Technologies CorporationEHA2022-12-06
D003540934B1RINN® Dentsply International Inc.EHA2022-11-27
D0035420501RINN® Dentsply International Inc.EHA2022-11-27
D0035500711RINN® Dentsply International Inc.EHA2022-11-27
D0035501001RINN® Dentsply International Inc.EHA2022-11-27
D0035503221RINN® Dentsply International Inc.EHA2022-11-27
D0035506611RINN® Dentsply International Inc.EHA2022-11-27
D0035507721RINN® Dentsply International Inc.EHA2022-11-27
D0035507771RINN® Dentsply International Inc.EHA2022-11-27