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, air-powered, dental
510(k) Number K170236
Device Name Dental Low-speed Turbine Handpiece
Applicant
Guangdong JINME Medical Technology Co., Ltd.
A15, New Light Source Industrial Base, Nanhai District
Foshan,  CN 528000
Applicant Contact Kristi Yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou S
Guangzhou,  CN 510663
Correspondent Contact Cecilia Ceng
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received01/25/2017
Decision Date 11/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-