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Is my Software a Medical Device? Use the Digital Health Policy Navigator

FDA Law

If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.” The flowchart can be downloaded here.

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Case Study: Six single-unit anterior crowns featuring KATANA™ multilayered Zirconia material

CDOCS

Furthermore, upon clinical examination and evaluation of radiographs, a diagnosis of recurrent decay was established on teeth #s 6 through 11.</span></p> jpg]</span><br /> <em style="font-family: ubuntu;"><span style="font-size: 11px;">Figure 1: Pre-op photo of teeth #s 6-11.</span></em></p>

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Interdisciplinary Case Report

CDOCS

We need to recognize how clinical dentistry has become intertwined with digital technologies to synergistically assist us in providing enhanced diagnosis with safe and predictable treatment outcomes. & The manufacture of a screw-retained or cementable implant crown and Atlantis abutments comes with a significant cost savings.