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 K212910
Device Name Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
Applicant
Shenzhen Carejoy Technology Co., Ltd.
5 / F, Building E, No.10, East Snow Science And Technology,
On Sakata Street, Longgang District
Shenzhen,  CN 518129
Applicant Contact Wei Hui
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 1407, Jingting Building, Dongzhou Community,
Guangming Street, Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number872.4200
Classification Product Code
EFB  
Subsequent Product Code
EGS  
Date Received09/13/2021
Decision Date 11/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-