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 K240672
Device Name Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
Applicant
Zhejiang Zahndent Biotechnology Co., Ltd.
#203, Bldg. 8, Lecheng Industrial Park, Xinqian
Huangyan District
Taizhou,  CN 318020
Applicant Contact Yaping Huang
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 304, Bldg. A, # 62 Nanyun 2nd Rd.
Science Town, Huangpu District
Guangzhou City,  CN 510663
Correspondent Contact Shangfeng Jiang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/11/2024
Decision Date 06/07/2024
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
-
-