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 Crown And Bridge, Temporary, Resin
510(k) Number K261261
Device Name Dura-Arch
Applicant
Hangzhou SHINING3D Dental Technology Co., Ltd.
9-5-2, Tri-River Valley, Wenyan St., Xiaoshan
Hangzhou,  CN 311258
Applicant Contact Yuqi Chen
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact Dave Yungvirt
Regulation Number872.3770
Classification Product Code
EBG  
Subsequent Product Code
PZY  
Date Received04/16/2026
Decision Date 04/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-