FONA STELLARIS

GUDID D7641000055741

FONA STELLARIS S0 SENSOR BASIC KIT, 2.7M/9FT

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

• Primary Device ID: D7641000055741
• NIH Device Record Key: be7940b7-1430-4deb-a873-a00d407db43d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FONA STELLARIS
• Version Model Number: 100005574
• 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	D7641000055741 [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 STELLARIS]

• D7641000055751: FONA STELLARIS S0 SENSOR BASIC KIT, .9M/3FT
• D7641000055661: FONA STELLARIS S1 SENSOR BASIC KIT, 1.8M/6FT
• D7641000054181: FONA STELLARIS S0 SENSOR SHIP KIT, 1.8M/6FT
• D764B13162000: FONA STELLARIS S0 SENSOR
• D764B12162000: FONA STELLARIS S2 SENSOR
• D764B11162000: FONA STELLARIS S1 SENSOR
• D7641000055741: FONA STELLARIS S0 SENSOR BASIC KIT, 2.7M/9FT
• D7641000055731: FONA STELLARIS S1 SENSOR BASIC KIT, .9M/3FT
• D7641000055721: FONA STELLARIS S1 SENSOR BASIC KIT, 2.7M/9FT
• D7641000055711: FONA STELLARIS S2 SENSOR BASIC KIT, .9M/3FT
• D7641000055701: FONA STELLARIS S2 SENSOR BASIC KIT, 2.7M/9FT
• D7641000055671: FONA STELLARIS S0 SENSOR BASIC KIT, 1.8M/6FT
• D7641000055651: FONA STELLARIS S2 SENSOR BASIC KIT, 1.8M/6FT
• D7641000054201: FONA STELLARIS S0 SENSOR SHIP KIT, .9M/3FT
• D7641000054191: FONA STELLARIS S0 SENSOR SHIP KIT, 2.7M/9FT
• D7641000054121: FONA STELLARIS S1 SENSOR SHIP KIT, .9M/3FT
• D7641000054111: FONA STELLARIS S1 SENSOR SHIP KIT, 2.7M/9FT
• D7641000054101: FONA STELLARIS S1 SENSOR SHIP KIT, 1.8M/6FT
• D7641000053931: FONA STELLARIS S2 SENSOR SHIP KIT, .9M/3FT
• D7641000053921: FONA STELLARIS S2 SENSOR SHIP KIT, 2.7M/9FT
• D7641000053911: FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT