SURGmatic S15 L Pro S15 L Pro

GUDID EKAV101440000

The SURGmatic S15 L Pro handpiece is intended for: • Oral, jaw and facial surgery • Tooth extraction procedures • Root resection • Osteotomy • Removal of carious material • Tooth, cavity and crown preparations • Processing of fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and / or oral surgery.

KaVo Dental GmbH

Dental power tool system handpiece, line-powered

• Primary Device ID: EKAV101440000
• NIH Device Record Key: 5281cc50-5b1c-4974-97d5-5c592fac9518
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGmatic S15 L Pro
• Version Model Number: 1.014.4000
• Catalog Number: S15 L Pro
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101440000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213139

FDA Product Code

• EGS: Handpiece, contra- and right-angle attachment, dental

Sterilization

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

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

[EKAV101440000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-21
• Device Publish Date: 2022-03-11

Devices Manufactured by KaVo Dental GmbH

• 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
• EKAV101509600 - INTRA LUX KL 703 LED Planmeca: 2023-04-24
• EKAV100703380 - Prophylaxe Set 2008: 2022-08-16 This is a medical device.
• EKAV200009220 - PROPHYflex perio tip: 2022-08-16 This is a medical Device.