FONA STELLARIS

GUDID D7641000053911

FONA STELLARIS S2 SENSOR SHIP KIT, 1.8M/6FT

SIRONA DENTAL, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: D7641000053911
• NIH Device Record Key: b5e33495-7df8-4d09-a159-a72a4f9e0d1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FONA STELLARIS
• Version Model Number: 100005391
• 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	D7641000053911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093453

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: 4
• 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