XIOS

GUDID D764B10700181

SIRONA S2 300 SENSOR SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG)

SIRONA DENTAL, INC.

Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: D764B10700181
• NIH Device Record Key: 08e3d2bd-2396-44a9-a01e-c90983830ed3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XIOS
• Version Model Number: B1070018
• Company DUNS: 078613913
• Company Name: SIRONA DENTAL, INC.
• Device Count: 300
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	D764B10700180 [Unit of Use]
HIBCC	D764B10700181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963664

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

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]

• D76461736241: SIRONA HOLDER STARTER KIT S2 SHEATH
• D76462018211: SIRONA XIOS+ HOLDER STARTER KIT S2 SHEATH
• D76462018131: SIRONA XIOS+ HOLDER STARTER KIT S1 SHEATH
• D76461765511: SIRONA ENDO HLDRR ASSY KIT
• D76461765441: SIRONA ENDODONTIC TAB ASY KIT GREEN
• D76461765361: SIRONA BITEWING HLDR ASSY KIT RED
• D76461765281: SIRONA PERIAPICAL HLDR ASY KIT YELLOW
• D76461765101: SIRONA ANTERIOR HLDR ASY KIT BLUE
• D76461736321: SIRONA HOLDER STARTER KIT S1 SHEATH
• D764B10700181: SIRONA S2 300 SENSOR SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D764B10700171: SIRONA S1 300 SENSOR SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D76461490041: SIRONA XIOS+ SENSOR SHEATH SIZE 2 UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D76461489981: SIRONA XIOS+ SENSOR SHEATH SIZE 1 UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D76461443771: SIRONA USB 2 SHIPPING KIT
• D76461443511: USB A/B 3M BLACK CABLE W/FERRITE
• D76461442861: SIRONA PHX SENSOR SIZE 1 SHIP KIT
• D76461442781: SIRONA PHX SENSOR SIZE 2 SHIP KIT