FONA ELITE

GUDID D764B12110001

FONA ELITE SENSOR SIZE 2 SHIP KIT

SIRONA DENTAL, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: D764B12110001
• NIH Device Record Key: e17cbd16-86a9-49d5-a343-5e854a0f4686
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FONA ELITE
• Version Model Number: B1211000
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D764B12110001 [Primary]

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-12-09
• Device Publish Date: 2016-09-09

On-Brand Devices [FONA ELITE]

• D764B11110001: FONA ELITE SENSOR SIZE 1 SHIP KIT
• D764B10730591: FONA ELITE STARTER KIT SIZE 0
• D764B10730581: FONA ELITE STARTER KIT SIZE 1
• D764B10730571: FONA ELITE STARTER KIT SIZE 2
• D764B22721000: FONA ELITE REMOTE ASSY
• D764B22720001: FONA ELITE REMOTE SHIP KIT
• D764B13111000: FONA ELITE SENSOR SIZE 0
• D764B13110451: FONA ELITE SENSOR SIZE 0 KIT
• D764B13110001: FONA ELITE SENSOR SIZE 0 SHIP KIT
• D764B12111121: FONA ELITE REPLACEABLE CABLE KIT 3 FT.
• D764B12111111: FONA ELITE REPLACEABLE CABLE KIT 9 FT.
• D764B12111101: FONA ELITE REPLACEABLE CABLE KIT 6 FT.
• D764B12111000: FONA ELITE SENSOR SIZE 2
• D764B12110451: FONA ELITE SENSOR SIZE 2 KIT
• D764B12110001: FONA ELITE SENSOR SIZE 2 SHIP KIT
• D764B11111000: FONA ELITE SENSOR SIZE 1
• D764B11110451: FONA ELITE SENSOR SIZE 1 KIT