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 Denture, Plastic, Teeth
510(k) Number K060565
Device Name CONDYLAFORM II NFC
Applicant
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact DONNA M HARTNETT
Correspondent
Ivoclar Vivadent, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact DONNA M HARTNETT
Regulation Number872.3590
Classification Product Code
ELM  
Date Received03/03/2006
Decision Date 05/08/2006
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
-
-