XIOS XG WIFI

GUDID D76464286481

XIOS XG SELECT WIFI SIZE 0, 45CM SPARE

SIRONA DENTAL, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: D76464286481
• NIH Device Record Key: d1608675-2be1-42c2-9d93-ee0222b7b408
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XIOS XG WIFI
• Version Model Number: 6428648
• 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: 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	D76464286481 [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

On-Brand Devices [XIOS XG WIFI]

• D76464286631: XIOS XG SUPREME WIFI SIZE 1, 45CM SPARE
• D76464286711: XIOS XG SUPREME WIFI SIZE 0, 45CM SPARE
• D76464286551: XIOS XG SUPREME WIFI SIZE 2, 45CM SPARE
• D76464286481: XIOS XG SELECT WIFI SIZE 0, 45CM SPARE
• D76464286221: XIOS XG SELECT WIFI SIZE 1, 45CM SPARE
• D76464286141: XIOS XG SELECT WIFI SIZE 2, 45CM SPARE
• D76464063051: XIOS XG SUPREME WIFI SIZE 0, 45CM SPARE
• D76464062971: XIOS XG SUPREME WIFI SIZE 1, 45CM SPARE
• D76464062891: XIOS XG SUPREME WIFI SIZE 2, 45CM SPARE
• D76464062711: XIOS XG SELECT WIFI SIZE 0, 45CM SPARE
• D76464062631: XIOS XG SELECT WIFI SIZE 1, 45CM SPARE
• D76464062551: XIOS XG SELECT WIFI SIZE 1, 45CM SPARE
• D76464045321: XIOS XG WIFI SENSOR CABLE KIT 270CM (9')
• D76464045241: XIOS XG WIFI SENSOR CABLE KIT 180CM (6')
• D76464045161: XIOS XG WIFI SENSOR CABLE KIT 90CM (3')
• D76464044821: XIOS XG WIFI SENSOR CABLE KIT 45CM (18")
• D76464043831: XIOS XG DOCKING STATION SPARE KIT
• D76464043830: XIOS XG WIFI DOCKING STATION ASSY
• D76464043670: XIOS XG WIFI INTERFACE ASSY
• D76464022701: XIOS XG WIFI SUPREME S2
• D76464022621: XIOS XG WIFI SUPREME S1
• D76464022541: XIOS XG WIFI SUPREME S0
• D76464022131: XIOS XG WIFI SELECT S2
• D76464022051: XIOS XG WIFI SELECT S1
• D76464021971: XIOS XG WIFI SELECT S0
• D76464021551: XIOS XG WIFI PACKAGE