SONICflex clean Tip No. 48 clean Tip No 48

GUDID EKAV100381670

This is a medical device.

Kaltenbach & Voigt GmbH

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• Primary Device ID: EKAV100381670
• NIH Device Record Key: 05534e6b-7ea2-4184-ba71-0071b66b5de9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONICflex clean Tip No. 48
• Version Model Number: 0.571.0401
• Catalog Number: clean Tip No 48
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV100381670 [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

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

[EKAV100381670]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [SONICflex clean Tip No. 48]

• EKAV057104010: This is a medical device.
• EKAV100381670: This is a medical device.