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 K142623
Device Name PANAVIA SA Cement Plus Handmix
Applicant
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f, 1-1-3, Otemachi
Chiyoda Ku,  JP 1000004
Applicant Contact Michio Takigawa
Correspondent
Kuraray Noritake Dental, Inc.
Ote Center Bldg. 7f, 1-1-3, Otemachi
Chiyoda Ku,  JP 1000004
Correspondent Contact Michio Takigawa
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/16/2014
Decision Date 02/26/2015
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
-
-