elements e-motion elements e-motion

GUDID EKAV101348000

The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation.

Kaltenbach & Voigt GmbH

Dental delivery system

• Primary Device ID: EKAV101348000
• NIH Device Record Key: 46b1c16a-d8d2-4735-8eab-67d16285a0a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: elements e-motion
• Version Model Number: 1.013.4800
• Catalog Number: elements e-motion
• Company DUNS: 332864359
• Company Name: Kaltenbach & Voigt GmbH
• 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: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com
• Phone: +18005377123
• Email: KerrCustCare@kavokerr.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101348000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163317

FDA Product Code

• EBW: Controller, foot, handpiece and cord

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-31
• Device Publish Date: 2020-03-23

On-Brand Devices [elements e-motion]

• EKAV101348000: The dental treatment unit running as a desktop unit is intended for use in the field of dentistr
• EKAV101333000: The dental treatment unit running as a desktop unit is intended for use in the field of dentistr