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 Handpiece, Direct Drive, Ac-Powered
510(k) Number K201993
Device Name E-connect S Endo Motor with built-in Apex Locator
Applicant
Changzhou Sifary Medical Technology Co., Ltd.
#99 Qingyang Rd., Xuejia County, Xinbei District
Changzhou,  CN 213000
Applicant Contact Amanda Zhu
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 508, Block C, # 1029 Nanhai Ave., Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number872.4200
Classification Product Code
EKX  
Subsequent Product Code
LQY  
Date Received07/17/2020
Decision Date 01/29/2021
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
-
-