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 Activator, Ultraviolet, For Polymerization
510(k) Number K221194
Device Name LEDEX
Applicant
Dentmate Technology Co. , Ltd.
8f, #8-11, Sec. 1, Zhongxing Rd.,
Wugu District,
New Taipei,  TW 24872
Applicant Contact Cheng-Feng Chou
Correspondent
Dentmate Technology Co. , Ltd.
8f, #8-11, Sec. 1, Zhongxing Rd.,
Wugu District,
New Taipei,  TW 24872
Correspondent Contact Cheng-Feng Chou
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received04/25/2022
Decision Date 09/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-