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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K220577
Device Name Dental Handpiece, Model CA160, CA160L, and CA500L
Applicant
Micro-Nx Co., Ltd.
22 Maeyeo-Ro 1 Gil
Dong-Gu,  KR 41059
Applicant Contact Sojeong Park
Correspondent
K-Bio Solutions
201 S. 4th St., Suite 727
San Jose,  CA  95112
Correspondent Contact Seohee Kwon
Regulation Number872.4200
Classification Product Code
EGS  
Date Received02/28/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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