Intraoral Sensor Holders Arms and Rings

GUDID D764B02100001

Anterior Arm

SIRONA DENTAL, INC.

Dental x-ray film holder, reusable

• Primary Device ID: D764B02100001
• NIH Device Record Key: e8b68d2a-996d-42d0-bfaa-77075b8e1f9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intraoral Sensor Holders Arms and Rings
• Version Model Number: B0210000
• 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	D764B02100001 [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.

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• 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