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 Powder, Porcelain
510(k) Number K241715
Device Name Dental Glass Ceramics Blocks (HT,LT,ST)
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
#9 Dushan Rd.
Economic And Technological Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Jinzhong Xu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lujiazui Rd.,
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/14/2024
Decision Date 07/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-