Product Risk Information

Nobel Biocare Implant and Esthetic Solutions

Nobel Biocare manufactures dental implants from biocompatible titanium. Nobel Biocare implants are supplied with different types of titanium and hydroxy apatite surfaces. Nobel Biocare dental implants are intended for use in either the upper and/or the lower jaw to support prosthetic devices, such as artificial teeth. They function to restore the physical appearance and the chewing function of patients with partial or full tooth loss. Nobel Biocare's dental implants are indicated for integration with the bones of patients. They enable restorations that range from replacement of one single tooth to an entire arch of bridgework or as stabilizing elements for overdenture applications.

Nobel Biocare also manufactures restorative components from ceramics, titanium, polymers and gold alloy. For example, Procera and NobelRondo products are made from biocompatible ceramics, zirconia, alumina, and/or porcelains.

Nobel Biocare's line of Procera products includes crowns, bridges, laminates, and abutments. The Procera products are used in the restoration of existing teeth, the replacement of missing teeth, or the restoration of dental implants. Procera crowns may replace one single tooth or an entire arch of bridgework.

NobelRondo is dental ceramic porcelain used to finish a crown, bridge, or veneer to achieve desired colors and consistency of finish.

Precautions for Restorative Treatment

Prerestorative patient evaluation is necessary to determine any factors that put the patient at risk from the restoration placement procedure itself or factors that may affect healing capacities of the associated soft tissue. Restorative design must accommodate individual patient conditions such as bruxism (grinding or clenching of teeth) or unfavorable jaw relationships to reduce the risk of overload or fatigue failure and treatment is contraindicated if adequate accommodation cannot be accomplished. Please consult your dentist for more information on treatment planning and medical evaluation.

Precautions for Implant Treatment

Nobel Biocare dental implants should not be used in patients who are medically unfit to participate in a general oral surgical procedure. Prior to receiving Nobel Biocare dental implants, patients must undergo a medical evaluation to determine whether the implant placement procedure would pose any health risks, and whether any factors exist, that may affect the healing capacities of either their bones or their associated soft tissues. Patients who have medical or other conditions that may interfere with the healing process of either their bones or soft tissues (e.g., connective tissue disorders, steroid therapy, bone infections, cigarette smoking) must carefully evaluate, with their dentists, the potential risks and benefits of using dental implants.

Nobel Biocare dental implants should not be used in patients that have inadequate amounts of residual bone to permit placement of implants in sufficient size and numbers to support their biomechanical loads. Mechanical failures, including fatigue fracture of implants, prosthetic screws, and/or abutment screws, may occur if dental implants are insufficient in size or number to support their biomechanical loads, or are not properly positioned. To reduce the risk of overload or fatigue failure, dentists must place the implants and design prosthetics to accommodate the physical or medical conditions of their patients, such as bruxism (i.e., grinding or clenching of teeth) or unfavorable jaw relationships. Nobel Biocare dental implants should not be used if dentists cannot adequately accommodate an individual patient's physical or medical conditions. Please consult your dentist for more information on treatment planning and medical evaluation.