Intraoral Sensor Holders Arms and Rings

GUDID D764B02100001

Anterior Arm

SIRONA DENTAL, INC.

Dental x-ray film holder, reusable
Primary Device IDD764B02100001
NIH Device Record Keye8b68d2a-996d-42d0-bfaa-77075b8e1f9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntraoral Sensor Holders Arms and Rings
Version Model NumberB0210000
Company DUNS078613913
Company NameSIRONA DENTAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com
Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com
Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com
Phone800.659.5977
Emailimagingsupportus@dentsplysirona.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD764B02100001 [Primary]

FDA Product Code

EHAAligner, Beam, X-Ray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

Devices Manufactured by SIRONA DENTAL, INC.

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D7641000053251 - AimRight2022-12-15 AimRight Sensor Holder, PA-Yel. S2 4pc
D7641000053301 - AimRight2022-12-15 AimRight Sensor Holder, BW-Red S1 2PC
D7641000053311 - AimRight2022-12-15 AimRight Sensor Holder, BW-Red S2 2PC
D7641000053321 - AimRight2022-12-15 AimRight Sensor Holder, ANT-Blue S1 2PC
D7641000053331 - AimRight2022-12-15 AimRight Sensor Holder, ANT-Blue S2 2PC
D7641000053341 - AimRight2022-12-15 AimRight Aiming Ring, Red 1 PC
D7641000053451 - AimRight2022-12-15 AIMRIGHT ADHESIVE HOLDERS SAMPLER

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