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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K213897
Device Name Pro M Class
Applicant
Saeyang Microtech Co., Ltd.
348, Seongseo-Ro
Daegu,  KR 41065
Applicant Contact Chang Hun Jeon
Correspondent
KMC, Inc.
Rm. 1709, 123, Digital-Ro 26-Gil
Guro-Gu,  KR 08390
Correspondent Contact DongHa Lee
Regulation Number872.4200
Classification Product Code
EKX  
Date Received12/14/2021
Decision Date 09/19/2022
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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