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 Bracket, Ceramic, Orthodontic
510(k) Number K180952
Device Name Ceramic Bracket
Applicant
Mem Dental Technology Co., Ltd.
2f., #22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist.
Tainan City,  TW 74146
Applicant Contact Anita Chen
Correspondent
Mem Dental Technology Co., Ltd.
2f., #22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist.
Tainan City,  TW 74146
Correspondent Contact Anita Chen
Regulation Number872.5470
Classification Product Code
NJM  
Date Received04/11/2018
Decision Date 06/07/2019
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
-
-