PROPHYflex 4 Wave 4 Perio Kit

GUDID EKAV101194030

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 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: EKAV101194030
• NIH Device Record Key: cf734c71-770f-4466-8b69-4d249835410f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPHYflex 4 Wave
• Version Model Number: 1.011.9403
• Catalog Number: 4 Perio Kit
• 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: true
• 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
• 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

• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101194030 [Primary]

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

[EKAV101194030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-12
• Device Publish Date: 2020-03-04

On-Brand Devices [PROPHYflex 4 Wave]

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