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 Material, Tooth Shade, Resin
510(k) Number K241673
Device Name Denture Base Resin (PN-Denture (Red, White))
Applicant
Shenzhen Piocreat 3D Technology Co., Ltd.
Rm.1308 Bldg. 3, Jincheng Ind Park,Longhua Dist
Shenzhen,  CN 518109
Applicant Contact Jason Cai
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBG   EBI   ELM   PZY  
Date Received06/11/2024
Decision Date 10/15/2024
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
-
-