PROPHYflex 4 Wave PROPHYflex 4 Wave

GUDID EKAV300280000

This is a medical device.

Kaltenbach & Voigt GmbH

Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece Dental abrasive air jet system handpiece 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.