Intraoral Sensor Holder Arms and Rings

GUDID D764B10731001

AimRight Universal Aiming Ring

SIRONA DENTAL, INC.

Dental x-ray film holder, reusable Dental x-ray film holder, reusable Dental x-ray film holder, reusable Dental x-ray film holder, reusable

• Primary Device ID: D764B10731001
• NIH Device Record Key: e7af1d31-0840-45d5-a058-9e90aceb704a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intraoral Sensor Holder Arms and Rings
• Version Model Number: B1073100
• Company DUNS: 078613913
• Company Name: SIRONA DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com
• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com
• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com
• Phone: 800.659.5977
• Email: imagingsupportus@dentsplysirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D764B10731001 [Primary]

FDA Product Code

• EHA: Aligner, Beam, X-Ray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by SIRONA DENTAL, INC.

• D7641000053241 - AimRight: 2022-12-15 AimRight Sensor Holder, PA-Yel. S1 4pc
• D7641000053251 - AimRight: 2022-12-15 AimRight Sensor Holder, PA-Yel. S2 4pc
• D7641000053301 - AimRight: 2022-12-15 AimRight Sensor Holder, BW-Red S1 2PC
• D7641000053311 - AimRight: 2022-12-15 AimRight Sensor Holder, BW-Red S2 2PC
• D7641000053321 - AimRight: 2022-12-15 AimRight Sensor Holder, ANT-Blue S1 2PC
• D7641000053331 - AimRight: 2022-12-15 AimRight Sensor Holder, ANT-Blue S2 2PC
• D7641000053341 - AimRight: 2022-12-15 AimRight Aiming Ring, Red 1 PC
• D7641000053451 - AimRight: 2022-12-15 AIMRIGHT ADHESIVE HOLDERS SAMPLER