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 K240337
Device Name Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Applicant
Guangdong Jinme Medical Technology Co., Ltd.
Rm. 301, 401, 501, Block #3, Wanyang Science Park,
84 Taoyuan E. Rd. Shishan Town, Nanhai District
Foshan,  CN 528200
Applicant Contact Ying Yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District, Guangzhou
Guangdong,  CN
Correspondent Contact Cassie Lee
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received02/05/2024
Decision Date 11/13/2024
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
-
-