FONA CDR DICOM

GUDID D764B10351060

FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)

SIRONA DENTAL, INC.

Diagnostic x-ray digital imaging system workstation application software

• Primary Device ID: D764B10351060
• NIH Device Record Key: e820f0f7-724a-4874-8765-ff7c1434db3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FONA CDR DICOM
• Version Model Number: B1035106
• Company DUNS: 078613913
• Company Name: SIRONA DENTAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D764B10351060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933455

FDA Product Code

• EAP: Unit, X-Ray, Intraoral

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-09
• Device Publish Date: 2016-09-09

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