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 K012442
Device Name MODIFICATION TO CLEARFIL SE BOND
Applicant
KURARAY MEDICAL INC.
30TH FL. METLIFE BUILDING
200 PARK AVENUE
NEW YORK,  NY  10166
Applicant Contact MASAYA SASAKI
Correspondent
KURARAY MEDICAL INC.
30TH FL. METLIFE BUILDING
200 PARK AVENUE
NEW YORK,  NY  10166
Correspondent Contact MASAYA SASAKI
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/31/2001
Decision Date 09/10/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-