There was a time when dental implants were very specialized and were only available from a select few laboratories. Those days are gone and implants are now part of the offering seen in almost every lab. Much like the conventional crowns and removable appliances we have always done, implant cases can now also be done in a wide variety of materials and techniques. However, when we construct restorations for implants the rules are not the same as they are for conventional restorations.
FDA Clearance Overview
An implant is a Class II medical device which requires quite a bit more regulation regarding how it is handled and applied. Some view this added layer of regulation as an inconvenience, but contrary to that opinion this scrutiny actually helps the lab to know they are doing procedures properly while maintaining a process for success and quality assurance. It also opens up the chance to use components from aftermarket manufacturers that specialize in just restorative technology. When these companies create compatible components and have them verified by the FDA for compliance the FDA considers the following the factors before granting clearance for compatibility:
- fabrication process
- quality assurance
- dimensional accuracy to the original component.
Generic Implant Components
When the FDA grants clearance (known as “510(k)”) it tells us this product is as good if not better than the original. We use generic drugs all day long all across the country, so why should we hesitate to use a component that has been certified in our labs? The dental industry is a little bit late to accepting and adopting this model for their implant restorations, but it is slowly and surely beginning to take advantage of this business model. This shift is being driven by three key factors that are unique to these generic versions:
- economic advantages
- ease of purchasing
- added benefits
Remember, the FDA has deemed that these products are as good, if not better in comparison to those produced by the original manufacturers. The implant industry has matured to a point that laboratories are benefiting from having so many options to choose from – while saving money. This proliferation of choices represents an opportunity to reduce costs and ultimately help patients with limited expendable income by offsetting insurance programs that sometimes only cover a minimal amount of the cost of implant restorations.
To learn more on this topic, including a step-by-step look at all implant components including titanium bases, scan bodies, bite verification cylinders, esthetic abutments, UCLA cylinders, and multi-unit abutments download our ebook, Implant Components: An Evaluation Guide here.
Thanks for reading,
John AckleyBack to All Posts