SURGmatic S201 XL Pro S201 XL Pro

GUDID EKAV101375410

This is a medical device.

Kaltenbach & Voigt GmbH

Dental power tool system handpiece, line-powered

• Primary Device ID: EKAV101375410
• NIH Device Record Key: cce23427-5e8f-4d31-a790-961d27c6dcbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGmatic S201 XL Pro
• Version Model Number: 1.013.7541
• Catalog Number: S201 XL Pro
• 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: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com
• Phone: +18882755286
• Email: customerservice@kavo.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -29 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101375410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140308

FDA Product Code

• EBW: Controller, foot, handpiece and cord

Sterilization

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

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

[EKAV101375410]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2020-01-24

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