XZeal Z70 Mobile XZ021

GUDID 00868923000237

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

XZEAL TECHNOLOGIES, INC.

Mobile intraoral dental x-ray system, digital

• Primary Device ID: 00868923000237
• NIH Device Record Key: 0378a9f1-d98a-440c-b68a-8a20ce17a9f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XZeal Z70 Mobile
• Version Model Number: On wheels
• Catalog Number: XZ021
• 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	00868923000237 [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

Devices Manufactured by XZEAL TECHNOLOGIES, INC.

• 00868923000206 - XZeal Z70 Wall: 2018-07-06 The XZeal Z70 Wall is an X-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.
• 00868923000213 - XZeal Z70 Wall: 2018-07-06 The XZeal Z70 Wall is an X-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.
• 00868923000220 - XZeal Z70 Wall: 2018-07-06 The XZeal Z70 Wall is an X­Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.
• 00868923000237 - XZeal Z70 Mobile: 2018-07-06The XZeal Z70 Mobile is an X-­Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.
• 00868923000237 - XZeal Z70 Mobile: 2018-07-06 The XZeal Z70 Mobile is an X-­Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures.
• 00868923000244 - XZeal Z70 Mobile VET: 2018-07-06 The XZeal Z70 Mobile VET is an X­-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures. F
• 00868923000251 - XZeal Z70 Wall VET: 2018-07-06 The XZeal Z70 Wall VET is an X­-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures. For
• 00868923000268 - XZeal Z70 Wall VET: 2018-07-06 The XZeal Z70 Wall VET is an X­-Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures. For
• 00868923000275 - XZeal Z70 Wall VET: 2018-07-06 The XZeal Z70 Wall VET is an X-­Ray source to produce intraoral images for the diagnosis of teeath and adjacent structures. For