We provide you with a completed FDA required form to make certain you have accurate documentation of each case you do.
Protect your dental practice.
Do business with a FDA compliant Dental Lab.
Dental appliances are now classified by the Food and Drug Administration as medical devices. Dental Laboratories are required to follow the same FDA guidelines and regulations as major medical device manufactures
At Biogenic Dental Laboratory, we realize that the quality of our dental restorations directly impact the safety and satisfaction of our dentists patients. We also understand that the combination of good design, good communication between our lab and our doctors, use of the highest quality, properly-tested materials, and in our case, use of digital processes, create better and easier-to-place finished restorations. A positive customer experience is what we work for every day.
Biogenic has put in place a system of policies and procedures, as required by the FDA, in order to insure that all of our dental appliances are manufactured in compliance with applicable codes, specifications and regulations, including the U.S. Code of Federal Regulations and more specifically, the U.S. Food and Drug Administration (FDA) Quality System/Good Manufacturing Practices (QS/GMP), Title 21, sub chapter H, Part 820.
Biogenic Dental Laboratory is proud to have established and implemented a quality system to ensure that the dental devices we manufacture exceed the expectations of our customers and their patients.
We have also established the BioCOMPLIANCE Material Tracking Form
to provide our customers with “peace of mind” in the dental appliances they provide to their patients. If you are a current Biogenic customer, you or your staff may have noticed our BioCOMPLIANCE Material Tracking Forms
included with your completed restoration or appliance.
This BioCOMPLIANCE Form
is provided to our customers to attach
with their patients file or records. The information disclosed on our BioCOMPLIANCE Form
includes the material names, lot/batch numbers and 510K registration numbers of the FDA registered/approved materials, attachments and implant components used in the fabrication of each patient’s dental device.