SONICflex 2008 L (Set) 2008 L Set

GUDID EKAV100716060

This is a medical device.

Kaltenbach & Voigt GmbH

Ultrasonic dental scaling/debridement system

• Primary Device ID: EKAV100716060
• NIH Device Record Key: f571518f-9918-4e28-a9cd-e6491aff4b8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONICflex 2008 L (Set)
• Version Model Number: 1.007.1606
• Catalog Number: 2008 L Set
• Company DUNS: 332864359
• Company Name: Kaltenbach & Voigt GmbH
• Device Count: 1
• DM Exempt: true
• 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: 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 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV100716060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080089

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

[EKAV100716060]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [SONICflex 2008 L (Set)]

• EKAV100716070: This is a medical device.
• EKAV100716060: This is a medical device.
• EKAV100716050: This is a medical device.
• EKAV100716040: This is a medical device.