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, Impression
510(k) Number K994190
Device Name IMPREGUM GARANT L DUOSOFT
Applicant
Espe Dental AG
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact ANDRERAS PETERMANN
Correspondent
Espe Dental AG
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Correspondent Contact ANDRERAS PETERMANN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received12/13/1999
Decision Date 01/27/2000
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
-
-