FDA Medical Device Manufacturer

FDA Registered Medical Device Manufacturer

Iverson is an FDA registered Medical Device Manufacturer

We are a FDA Registered Medical Device Manufacturer compliant and have clearance for the manufacturing, marketing, and distribution of Class 2 devices or below. Iverson is registered as a “validated milling center” for NHA as directed by the Acting Assistant Director of the Implantable Dental Device Team.

FDA Registered Medical Device Manufactured in house:

Click Here to view to our FDA Registration

  • Dental Implant surgical guides
  • NHA – Endosseous Dental Implant Abutment
  • 3D printed denture teeth
  • Milled Titanium bars

ONLY THE HIGHEST QUALITY MATERIALS

In order to be an FDA Registered Medical Device Manufacturer, we register yearly with the FDA. We are also required to list the devices that are made there and how they function. If a device requires a premarket submission before being marketed in the United Sates, then Iverson dental labs will also provide the FDA premarket submission number.

These medical devices have been specially made to better assist dental professionals and their patients. We strive to continue to be the ultimate resource for our clients. That’s why our research and development team and come together to provide this list of FDA approved medical devices we fabricate in house.

We believe that creating medical devices that are FDA approved is important because, the devices location is known. In the case of a public health emergency, the nation will know whereto go to receive the proper solution.

Iverson dental labs will continue to create medical devices to better serve the public. furthermore, we will continue to have these future devices approved by the FDA.

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