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 Unit, Operative Dental
510(k) Number K231845
Device Name Dental unit Model: Mare
Applicant
Foshan Safety Medical Equipment Co., Ltd.
Floor 1,2,3, Bldg. 6-1, Lane 1, Dianbian E. Rd.
Nanyue, Shangan, Danzao Town, Nanhai
Foshan,  CN 528216
Applicant Contact May Xian
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park
#18 Shenzhou Rd., Huangpu
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/22/2023
Decision Date 02/28/2024
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
-
-