SONICflex implant set A 1.006.2027

GUDID EKAV100620270

This is a medical device

KaVo Dental GmbH

Ultrasonic dental scaling/debridement system

• Primary Device ID: EKAV100620270
• NIH Device Record Key: b652261b-9841-4378-a7d3-b8918bf7041f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONICflex implant set A
• Version Model Number: 1.006.2027
• Catalog Number: 1.006.2027
• Company DUNS: 333710619
• Company Name: KaVo Dental 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV100620270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080089

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

[EKAV100620270]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-10
• Device Publish Date: 2025-01-31

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