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Does the FDA approve dental implants?
New cosmetic procedures, both medical and dental, continue to be introduced as more individuals are starting to actively seek ways to improve their appearance. Oftentimes procedures become available to the American public without FDA approval, which is why many potential patients wonder if the FDA approves dental implants. The FDA is responsible for protecting and promoting public health, therefore undergoing treatments that are FDA approved provides patients with the assurance that these treatments are safe, effective and come with minimal risk. Potential dental implant patients will be happy to know that the FDA in fact, approves the procedure.
The Food and Drug Administration approved dental implants for long term stabilization after satisfactory technical and clinical evidence that the product was safe for public use and in fact had beneficial attributes was provided. The FDA granted its formal consent to use dental implants for long term treatment by approving both of its components: the titanium screw and the dental crown (the dental prosthetic most often used when undergoing implant treatments).
Titanium Screw
The titanium screw, which stabilizes the dental crown is approved as a Class III medical device, which means that is has general controls and premarket approval. The titanium screws are installed in the patient’s bone in the upper or the lower jaw through a controlled procedure. After the administration of a local anesthetic, small incisions are made in the gum line, which provide access to the jawbone below. Specialized drills are used to create small holes in the jaw for implant insertion. The implants are then placed in the spaces provided and a specialized wrench is used to secure the implant in place. Once properly placed, only the head or abutment, which connects to the dental crown or other dental prosthetic, is visible above the gum line.
Dental Crown
The second part of the dental implant procedure involves a dental crown, which is approved as Class I device. This means the FDA considers dental crowns to be safe. Being categorizes as a Class I device means that the potential of dental crowns being harmful is minimal.
Knowing that a medical or dental procedures is FDA approved is essential. Feel confident knowing that dental implants are safe, effective and provide stable, long-lasting results.