QUATTROcare plus Spray AMERICA 2141 AMERICA 2141

GUDID EKAV100538440

This is a medical device.

Kaltenbach & Voigt GmbH

Dental handpiece maintenance unit

• Primary Device ID: EKAV100538440
• NIH Device Record Key: 39e10a01-090b-4ad0-b86a-9784e51c47dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUATTROcare plus Spray AMERICA 2141
• Version Model Number: 1.005.3844
• Catalog Number: AMERICA 2141
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV100538440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071288

FDA Product Code

• EFB: HANDPIECE, AIR-POWERED, DENTAL

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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