Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K251407
Device Name Motor Handpiece and Control Unit (SDI10)
Applicant
Saeshin Precision Co., Ltd.
# 52, Secheon-Ro 1-Gil, Dasa-Eup, Dalseong-Gun
Deagu,  KR 42921
Applicant Contact San NamGung
Correspondent
E & M
D1474, Pyeongcheon Arco Tower, 230, Simin-Daro, Dongan-Gu
Anyangsi,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number872.4200
Classification Product Code
EBW  
Date Received05/06/2025
Decision Date 01/30/2026
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
-
-