SURGmatic S201 XL Pro

Basic Information

• Brand Name: SURGmatic S201 XL Pro
• Primary DI: EKAV101375410
• Version / Model: 1.013.7541
• Catalog Number: 1.013.7541
• Company Name: KaVo Dental GmbH
• Labeler DUNS: 333710619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-24
• Public Version: 5
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: cce23427-5e8f-4d31-a790-961d27c6dcbf

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBW	Controller, foot, handpiece and cord	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV101375410	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140308	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -29 – 50 Degrees Celsius