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

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBIORA EMDOGAIN(R)
Classification Namebiologic material, dental
Generic Nameenamel derivative
Regulation Number872.3930
ApplicantBIORA, INC.
PMA NumberP930021
Supplement NumberS001
Date Received01/05/1998
Decision Date05/18/1999
Product Code
NQA[ Registered Establishments with NQA ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for manufacturing and packaging changes for emdogain(r).
-
-