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 K935892
Device Name INDURENT GEL
Applicant
Zhermack Dental Production
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN C DICK, PH.D.
Correspondent
Zhermack Dental Production
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN C DICK, PH.D.
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/12/1993
Decision Date 10/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-