Elements 8:1 8:1

GUDID EKAV101167860

This is a 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 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: EKAV101167860
• NIH Device Record Key: 4f5300a5-e527-45e6-8792-f8c23cf0b5fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elements 8:1
• Version Model Number: 1.011.6786
• Catalog Number: 8:1
• 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: 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
• 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
• 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	EKAV101167860 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163239

FDA Product Code

• EFA: Handpiece, belt and/or gear driven, dental

Sterilization

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

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

[EKAV101167860]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-15
• Device Publish Date: 2021-03-05

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