Ki-20

Basic Information

• Brand Name: Ki-20
• Primary DI: 08809394970881
• Version / Model: Ki-20
• Company Name: SAEYANG MICROTECH CO.,LTD
• Labeler DUNS: 631078094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: fa300a79-2af2-4fa6-8186-77cb62744ab6

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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
38347	Dental power tool system handpiece, line-powered	A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809394970881	GS1

Premarket Submissions

Submission Number	Supplement Number
K141482	000