FDA compliance is critical to understand. Make certain YOU personally do business with an FDA compliant Laboratory. At Biogenic we take FDA rules and regulations deadly serious. We call it BioCOMPLIANCE!
Below is our policies and procedures manual. Full disclosure of our exact FDA COMPLIANT process.
Quality and peace of mind for you and your patients!
Are you aware that dental appliances are classified by the Food and Drug Administration as medical devices? And that Dental Laboratories are required to follow the same FDA guidelines and regulations as major medical device manufactures?
At Biogenic Dental Laboratory, werealizes that the quality of our dental restorations directly impact the safety and satisfaction of our customers. We further understand that good design, management, and continuous improvements to our products and processes create quality products. Therefore, Biogenic has put in place a system of policies and procedures, as required by the FDA, in order to insure that all 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, Subchapter H, Part 820.
Biogenic Dental Laboratory is proud to have established and implemented a “companywide” quality system, to ensure that the dental devices we manufacture meet or 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 Form”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.
Outlined below is a brief summary of the procedures and policies in place at Biogenic Dental Laboratory, so that the highest level of consistency and quality is achieved with each dental device we fabricate.
- Design Controls: Assuring a complete and accurate Work Authorization
Form(Rx) is received with every case and that the doctors signature
and license number appear on the Rx. (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 Biogenic Dental Laboratory.
Identification & Traceability: 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: System to establish and maintain procedures
for the acceptance of an incoming case.
1. Make sure all case items are disinfected (Universal Precaution),
2. Make sure all items needed for case fabrication are
included/received – Rx, case design, shade, alloy, bite,
impression, model(s), patient’s age & sex, etc.
3. Make sure all items received with a case are properly labeled
to prevent mix-up.
- Non-Conforming Product: System to document non-conforming
devices and what steps are taken to identify and correct a
non-conforming device.
VIII. Corrective & Preventive Action: Organized system to identify where
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), and Who the
device belongs too.
- X. 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 control (QC) of finished devices,
so only approved devices are released and any
non-conformances 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.
- Records: A product related document control system (Quality Manual)
to manage SOPs, Policies, Procedures, Work Instructions, Training
Records, Non-Conformances, etc.
- Statistical Techniques: System to track data (%) for non-conforming
products and review the data in department production meetings.
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