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 K161353
Device Name ESTELITE BULK FILL Flow
Applicant
Tokuyama Dental Corporation
38-9 Taitou 1-Chome, Taitou-Ku
Tokyo,  JP 110-0016
Applicant Contact KEITH A. BARRITT
Correspondent
Fish & Richardson, P.C.
1425 K St., NW, Suite 1100
Washington,  DC  20005
Correspondent Contact KEITH A. BARRITT
Regulation Number872.3690
Classification Product Code
EBF  
Date Received05/16/2016
Decision Date 04/03/2017
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
-
-