SMARTmatic ENDO S81 ENDO S81

GUDID EKAV101167800

This is an medical device.

Kaltenbach & Voigt GmbH

Dental power tool system handpiece, line-powered

• Primary Device ID: EKAV101167800
• NIH Device Record Key: 8ecbf181-4a18-40e2-b6a7-0242451f7739
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTmatic ENDO S81
• Version Model Number: 1.011.6780
• Catalog Number: ENDO S81
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101167800 [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

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

[EKAV101167800]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-08-03

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