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 and keep 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.

Below are our BioCOMPLIANCE policies and procedures:

Outlined below is a brief summary of the procedures and policies in place at Biogenic Dental Lab. You will receive the highest level of consistency and quality with each dental device we fabricate.

Assuring a complete and accurate Work Authorization Form(Rx) is received with every case. (The FDA considers the doctor responsible for the “design control”of the dental device).

  • Document Controls: Organized and structured system for maintaining records and documents, that specifically relate to the manufacture and fabrication of a dental device.
  • Purchasing Controls: Documentation that selected Vendors/Suppliers and their products are registered with the FDA. System to assure that materials utilized in the fabrication of a dental device meet the requirements and specification of the FDA and Biogenic Dental Laboratory.
  • Identification & Trace-ability Documented system (BioCOMPLIANCE Material Tracking Form) to track the lot numbers and batch numbers of materials used in the fabrication of each patients dental device.
  • Production & Process Controls: Written procedures (SOP’s) and Work Instructions to ensure that steps and tasks that can affect the quality of a device, are performed in a consistent manner. (This also includes what actions are to be taken if a processing failure occurs).
  • Acceptance Activities: Our system to establish and maintain procedures for the acceptance of an incoming case.
    • Make sure all case items are disinfected (Universal Precaution)
    • Make sure all items needed for case fabrication are included and received – Rx, case design, shade, alloy, bite, impression, model(s), patient’s age & amp; sex, etc.
    • Make sure all items received with a case are properly labeled
  • Non-Conforming Product: System to document non-conforming devices and what steps are taken to identify and correct a non-conforming device.
  • Corrective & Preventive Action: Organized system to identify if a failure in manufacturing has occurred and the action needed to correct or prevent the re-occurrence of a non-conforming device.
  • Label & Package Control:Documentation that allows a dental client to identify the contents of a package and
    • Who manufactured the device
    • Where the device was manufactured (country of origin)
    • Who the device belongs to
  • Handling, Storage, Distribution & Installation:
    • Handling - Procedures to prevent damage, mix-up, or contamination of a device during fabrication.
    • Storage - Procedures for the control of storage areas & stock rooms to prevent mix-up, damage, contamination or deterioration of products or materials prior to use.
    • Distribution - Procedures for the quality control of finished devices so only approved devices are released, and any others are corrected prior to distribution.
    • Installation - Procedures to inform the dental client when “special” insertion steps or care may be required for an appliance or restoration.