INTRA Surgery Handpiece 3610 N2 3610 N2

GUDID EKAV052456100

This is medical device.

Kaltenbach & Voigt GmbH

Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered Dental power tool system handpiece, line-powered

• Primary Device ID: EKAV052456100
• NIH Device Record Key: 69310cc3-d309-4e79-b21c-88cbefd95f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRA Surgery Handpiece 3610 N2
• Version Model Number: 0.524.5610
• Catalog Number: 3610 N2
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV052456100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073478

FDA Product Code

• EFB: HANDPIECE, AIR-POWERED, DENTAL

Sterilization

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

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

[EKAV052456100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-26

Devices Manufactured by Kaltenbach & Voigt GmbH

• EKAV101167860 - Elements 8:1: 2021-03-15 This is a medical device.
• EKAV100381670 - SONICflex clean Tip No. 48: 2021-03-09 This is a medical device.
• EKAV100729710 - Prophylaxe Set 2003: 2021-03-09
• EKAV100765500 - Prophylaxe Set 2008L/2018 violett: 2021-03-09
• EKAV100957450 - SMART LUX Case 619460L: 2021-03-09
• EKAV100957460 - SMART Case 619460C: 2021-03-09
• EKAV100957640 - PROPHYflex Perio Powder 20gr.: 2021-03-09
• EKAV100960480 - EXPERT LUX Case 680465LRN: 2021-03-09