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 K183537
Device Name PANAVIA SA Cement Universal
Applicant
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f, 1-1-3, Otemachi
Chiyoda-Ku,  JP 100-0004
Applicant Contact Yasujiro Ohara
Correspondent
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f, 1-1-3, Otemachi
Chiyoda-Ku,  JP 100-0004
Correspondent Contact Yasujiro Ohara
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Code
KLE  
Date Received12/19/2018
Decision Date 04/25/2019
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
-
-