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 K094007
Device Name UNICEM
Applicant
3M Espe AG Dental Products
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact DESI W SOEGIARTO
Correspondent
3M Espe AG Dental Products
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Correspondent Contact DESI W SOEGIARTO
Regulation Number872.3275
Classification Product Code
EMA  
Date Received12/28/2009
Decision Date 04/08/2010
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
-
-