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 Agent, Tooth Bonding, Resin
510(k) Number K024356
Device Name CLEARFIL SILANE KIT
Applicant
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Applicant Contact MASAYA SASAKI
Correspondent
Kuraray Medical, Inc.
101 E. 52nd St.
26th Floor
New York,  NY  10022
Correspondent Contact MASAYA SASAKI
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/30/2002
Decision Date 03/26/2003
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
-
-