SONICflex prep crown plain no. 98 A 1.008.6386

GUDID EKAV100863860

This is a medical device.

KaVo Dental GmbH

Ultrasonic dental scaling/debridement system

• Primary Device ID: EKAV100863860
• NIH Device Record Key: 98aecbd3-36da-4228-8ef5-2ce07a5c2539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SONICflex prep crown plain no. 98 A
• Version Model Number: 1.008.6386
• Catalog Number: 1.008.6386
• 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	EKAV100863860 [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

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

Moist Heat or Steam Sterilization

[EKAV100863860]

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

Devices Manufactured by KaVo Dental GmbH

• EKAV100620270 - SONICflex implant set A: 2025-02-10 This is a medical device
• EKAV100863840 - SONICflex prep crown round no. 97 A: 2025-02-10 This is a medical device
• EKAV100863860 - SONICflex prep crown plain no. 98 A: 2025-02-10This is a medical device.
• EKAV100863860 - SONICflex prep crown plain no. 98 A: 2025-02-10 This is a medical device.
• EKAV101537000 - DIAGNOcam Vision Full HD: 2024-12-11
• EKAV101112130 - DIAGNOcam Vision Full HD: 2024-02-09
• EKAV101315000 - DIAGNOcam Vision Full HD: 2024-02-09
• EKAV101402800 - MASTERmatic LUX M45 L: 2024-02-09
• EKAV101002870 - Refill PROPHYflex perio tip: 2023-04-25 PROPHYflex perio tip: Attachment for a focused beam for focused and gentle subgingival treatments as well as cleaning bridges, i