SMART Case 619460C 619460C

GUDID EKAV100957460

Kaltenbach & Voigt GmbH

Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic Dental power tool system handpiece, pneumatic

• Primary Device ID: EKAV100957460
• NIH Device Record Key: cb8a1399-dae8-4155-a375-f9e8b5cabcd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART Case 619460C
• Version Model Number: 1.009.5746
• Catalog Number: 619460C
• 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

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	EKAV100957460 [Primary]

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

Moist Heat or Steam Sterilization

[EKAV100957460]

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

Devices Manufactured by Kaltenbach & Voigt GmbH

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• 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
• EKAV100957460 - SMART Case 619460C: 2021-03-09
• EKAV100957640 - PROPHYflex Perio Powder 20gr.: 2021-03-09
• EKAV100960480 - EXPERT LUX Case 680465LRN: 2021-03-09