Regulatory Approval Process for Dental Implants and Components

From a regulatory perspective, since 1976, the evaluation and approval of safety, effectiveness and indication of use of dental implants and restorative components was based on the description of the device by the device evaluator whom might or might not have had a background in dentistry.

As long as the new product could be shown to be a “substantial equivalent” to other “predicate devices”, i.e. devices that were already on the market, physical testing data was not required prior to their approval. 

For example, the initial marketing of non-engaging abutments for clinical use in screw retained, splinted, fixed dental prosthesis appear to have been based on “substantial equivalence” to the original Brånemark’s “gold cylinder” prosthetic component or UCLA type abutments. The original “gold cylinder” was designed to fit on top of a solid flat surface, external hex implant (Skalal 1983).

Hollow implant housing with internal connections were approved following the claims for substantial equivalency of non-engaging abutments. There is lack of available peer-reviewed studies investigating the specifications of non-engaging abutments in conjunction with internally connecting implants. Thus, it would be prudent to carefully examine the conclusions drawn from clinical studies using dental implants and restorative components lacking safety and effectiveness data.  

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