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) | 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
Device Classification Name powder, porcelain
510(K) Number K121359
Device Name IPS 99 ONE AND IPS 99 CERAM
Applicant
IVOCLAR VIVADENT AG
175 pineview dr.
amherst,  NY  14228
Contact donna marie hartnett
Regulation Number872.6660
Classification Product Code
EIH  
Date Received05/07/2012
Decision Date 07/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-