Zirconia - The Truth

Replies to This Discussion

Permalink Reply by Ira N. Dickerman, CDT on April 8, 2010 at 8:28am

The purchase of raw zirconia for milling by dental laboratories seems to me to be a blind item. How are we to know what we are getting? If I have a Procera or Lava crown fabricated I am trusting the producer and supplier of those raw materials Nobel and 3M. If I order XYZ zirconia how can I know what I am getting? Is there a difference in the product that is clinically significant? As a supplier of Lava and Procera restorations to my Dr clients I have had very few failures. We understand that the design of the restoration understructure is important for proper ceramic support. Beyond that if the material is of a "lower quality" what type of failures will occur? Bond to ceramic? Understructure fracture? These are areas that I have not seen or heard discussed as of yet.

Permalink Reply by Mark Jackson RDT on April 27, 2010 at 12:17am

One serious problem we face is the FDA 510k application process. Manufacturers can simply take any isostatically pressed zirconia and file for a 510k provisional use application claiming it is "just like Lava". the problem is, there is no investigative process and dentists and labs are notoriously bad about reporting failed medical devices. Most labs are not FDA GMP compliant and have no quality systems or good manufacturing processes, and a total lack of documentation.

If we continue the way we are going, only the big manufacturers will be producing restorations and prosthetics. Hopefully the FDA will start enforcing the GMP compliance laws that have been effect since 2003, and hopefully WE in the dental community will start acting like the professionals we are supposed to be, following the rules and filing performance reports like the medical profession does.