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There is a lot of misinformation in the above answer.

Hello MrG, Contact me @[email protected] and I will provide you with an extensive list of FDA Cleared Ti Bases and Blanks that are on the market and can be modified in-house using any mill.

Hello DrG, I am going to assume you are a dentists. Please correct me if I am wrong. If that is the case, you are not required to have a "quality system" (QS) implemented as the FDA does not regulate the medical or dental practice. To cover your legal liabilities, I would strongly suggest a...

That is inaccurate. The FDA requirements are on the CAD and the milled components, not on the CAM or the mill. There is so much misinformation out there to scare you into buying overpriced systems like the Straumann or Sirona. The open systems are more affordable and easier to maintain. Most...

The pathway to FDA compliance for a CAD/CAM dental lab is no where near that intrusive. It sounds like you have described DAMAS which is not a regulatory requirement for any lab, DAMAS is overly complicated and has outlived its practicality and usefulness. The real FDA requirements are less...

The FDA does not regulate the practice of medicine or dentistry. Pretty much free to do as they can but carry the legal responsibility.

Hello Keith, do your "DESS Authorized" milling centers have a Quality System implemented?

Here is an excerpt from an article in the August issue of IDT titled "Under the Microscope". The article provides critical information on the FDA and the CAD/CAM dental lab. “Dental laboratories, whether they wanted to or not, have evolved from a cottage industry to manufacturers of product,”...

The question is not who is making the restoration, the question is are they selling the restoration outside of their business? An in house dental lab is not a commercial lab and as such, in today's regulatory environment, is exempt. This may change in the future as the FDA continues to provide...

A dentist with an in house lab is not viewed by the FDA as a commercial dental laboratory as long as the dentist is only doing lab work for his/her patients and not servicing other dentists outside of their practice. It is the commercial laboratory that is manufacturing for a number of...