• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name powder, porcelain
510(k) Number K071848
Device Name IPS INLINE POM SYSTEM
Original Applicant
IVOCLAR VIVADENT, INC.
175 pineview dr.
amherst,  NY  14228
Original Contact donna m hartnett
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/05/2007
Decision Date 08/30/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-