XZeal Z70 Wall XZ011

GUDID 00868923000206

The XZeal Z70 Wall is an X-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.

XZEAL TECHNOLOGIES, INC.

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 00868923000206
• NIH Device Record Key: 3aaba03c-710f-4814-82ba-62b95b7cb137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XZeal Z70 Wall
• Version Model Number: Small Arm
• Catalog Number: XZ011
• Company DUNS: 041863955
• Company Name: XZEAL TECHNOLOGIES, 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: false
• 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: 407 483-8859
• Email: info@xzeal.us

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868923000206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122582

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

On-Brand Devices [XZeal Z70 Wall]

• 00868923000220: The XZeal Z70 Wall is an X­Ray source to produce intraoral images for the diagnosis of teeath a
• 00868923000213: The XZeal Z70 Wall is an X-Ray source to produce intraoral images for the diagnosis of teeath an
• 00868923000206: The XZeal Z70 Wall is an X-Ray source to produce intraoral images for the diagnosis of teeath an