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 Cement, Dental
510(k) Number K252165
Device Name ZIRCONOMER P
Applicant
Shofu Dental Corporation
1225 Stone Dr.
San Marcos,  CA  92078
Applicant Contact Malzyner Mauro
Correspondent
Shofu Dental Corporation
1225 Stone Dr.
San Marcos,  CA  92078
Correspondent Contact Malzyner Mauro
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/10/2025
Decision Date 10/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-