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 K070956
Device Name SEA2 SELF ETCH ADHESIVE
Applicant
3M Espe Dental Products
3m Center; Bldg. 260-2a-11
St. Paul,  MN  55144 -1000
Applicant Contact KAREN O'MALLEY
Correspondent
3M Espe Dental Products
3m Center; Bldg. 260-2a-11
St. Paul,  MN  55144 -1000
Correspondent Contact KAREN O'MALLEY
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/05/2007
Decision Date 05/22/2007
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
-
-