RONDOflex powder 50m (1000g) NA

GUDID EKAV100059560

This is a medical device.

Kaltenbach & Voigt GmbH

Dental abrasive powder

• Primary Device ID: EKAV100059560
• NIH Device Record Key: e1d39a37-19a2-46a3-8d04-0c3ad6aa28c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RONDOflex powder 50m (1000g)
• Version Model Number: 1.000.5956
• Catalog Number: NA
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius
• Handling Environment Temperature: Between -50 Degrees Celsius and 80 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV100059560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042872

FDA Product Code

• KOJ: AIRBRUSH

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: 2016-09-26

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• EKAV100957460 - SMART Case 619460C: 2021-03-09
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