ELECTROmatic M-L M-L

GUDID EKAV101285380

Kaltenbach & Voigt GmbH

Dental delivery system

• Primary Device ID: EKAV101285380
• NIH Device Record Key: 6c7ed77b-d99f-49de-bfc6-e4be905d3f6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELECTROmatic M-L
• Version Model Number: 1.012.8538
• Catalog Number: M-L
• 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@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.com
• Phone: +18475506800
• Email: customerservice@kavokerr.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	EKAV101285380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163317

FDA Product Code

• EBW: Controller, foot, handpiece and cord

Sterilization

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

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

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• 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