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 Powder, Porcelain
510(k) Number K132230
Device Name ICE ZIRKON TRANSLUZENT
Applicant
Zirkonzahn Srl
67 Main St.
Silver Creek,  NY  14136
Applicant Contact DONNA M HARTNETT
Correspondent
Zirkonzahn Srl
67 Main St.
Silver Creek,  NY  14136
Correspondent Contact DONNA M HARTNETT
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/18/2013
Decision Date 11/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-