An FDA advisory panel will consider in July whether to down-classify blade-form endosseous dental implants from the highest risk category to a less stringent class.
The FDA is now proposing to reclassify this pre-amendments class III device into class II because the federal watchdog believes that special controls, together with general controls, can effectively mitigate risks to health posed by these devices, according to the agency’s federal register notice.
The agency noted that it has been reviewing these devices for many years and their risks are well known.
In addition the devices have demonstrated a high success rate in terms of remaining implanted and not needing removal, and the relatively few reported adverse events associated with them suggest that they have a strong long-term safety profile.
The federal watchdog’s Dental Products Panel of the Medical Devices Advisory Committee on July 18 will either reaffirm the highest risk Class III, or reclassify these devices into Class II and comment on whether the proposed Special Controls are adequate to reasonably ensure the devices’ safety and effectiveness.
The dental blade-form implant is intended to replace tooth roots and extend a support post through the gingival tissue into the oral cavity to restore chewing function. While these types of implants come in variety of shapes, in general they are rectangular with a narrow tapered edge much like a razor blade.
The dental implants are placed into the maxilla or mandible and are composed of a strong bio-compatible material like pure titanium, to support a dental restoration, such as a crown, bridge, or denture.
Blade form endosseous dental implants are one of the remaining pre-amendments Class III devices. They were originally placed into the highest risk class III category because they are implanted in the body and pose potential risks of spontaneous pain due to nerve impingement and perforation of the lingual and labial bony plates of the upper and lower jaws.
These dental implants are MRI incompatible and can migrate or heat while a patient is undergoing magnetic resonance imaging, and in can lead to local tissue or existing dentition degeneration, bone or nerve damage, infection and adverse tissue reaction, the federal watchdog notes. You can check with your dental implants Burbank CA or dental implants Anchorage dentists for the availability of this service.