PROPHYflex 4 Wave PROPHYflex 4 Wave

GUDID EKAV300280000

This is a medical device.

Kaltenbach & Voigt GmbH

Dental abrasive air jet system handpiece

• Primary Device ID: EKAV300280000
• NIH Device Record Key: b437c9d9-2563-47d0-a249-c6f73551acb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPHYflex 4 Wave
• Version Model Number: 3.002.8000
• Catalog Number: PROPHYflex 4 Wave
• 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: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com
• Phone: +18475506800
• Email: customerservice@kavo.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV300280000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181110

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

[EKAV300280000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-01
• Device Publish Date: 2020-03-24

On-Brand Devices [PROPHYflex 4 Wave]

• EKAV101194030: This is a medical device.
• EKAV300280000: This is a medical device.