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 K964323
Device Name CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL
Applicant
Fen Dental Mfg., Inc.
1819 S. May St., 2f
Chicago,  IL  60608
Applicant Contact ROBERT W BAUER, PH.D.
Correspondent
Fen Dental Mfg., Inc.
1819 S. May St., 2f
Chicago,  IL  60608
Correspondent Contact ROBERT W BAUER, PH.D.
Regulation Number872.3660
Classification Product Code
ELW  
Date Received10/30/1996
Decision Date 12/16/1996
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
-
-