FONA CDR

GUDID D764B11120501

FONA CDR SENSOR SIZE 1 SHIP KIT

SIRONA DENTAL, INC.

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: D764B11120501
• NIH Device Record Key: d0f2084f-645a-4c7e-8be9-fb1659b38c81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FONA CDR
• Version Model Number: B1112050
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D764B11120501 [Primary]

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: 2019-04-03
• Device Publish Date: 2016-09-09

On-Brand Devices [FONA CDR]

• D764B11120501: FONA CDR SENSOR SIZE 1 SHIP KIT
• D764B10730921: FONA CDR UNIVERSAL HOLDERS STARTER KIT - SIZE 2
• D764B10730911: FONA CDR UNIVERSAL HOLDERS STARTER KIT - SIZE 1
• D764B10730701: FONA CDR UNIVERSAL HOLDERS STARTER KIT
• D764B22521000: FONA USB REMOTE ASSY
• D764B22520001: FONA USB REMOTE SHIP KIT
• D764B13121000: FONA CDR SENSOR SIZE 0
• D764B13120501: FONA CDR SENSOR SIZE 0 SHIP KIT
• D764B12121000: FONA CDR SENSOR SIZE 2
• D764B12120501: FONA CDR SENSOR SIZE 2 SHIP KIT
• D764B11121000: FONA CDR SENSOR SIZE 1