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 Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K260376
Device Name Denture Base
Applicant
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Applicant Contact Zheng Maggie
Correspondent
Shandong Huge Dental Material Corporation
# 68 Shanhai Rd., Donggang District
Rizhao City,  CN 276800
Correspondent Contact Zheng Maggie
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/05/2026
Decision Date 05/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-