Overview: This article provides essential instructions for the intended use, indications, and safety protocols for dental implant abutments. It is intended for dental practitioners to ensure proper patient selection and device maintenance.
Intended Use and Description
Dental implant abutments support a prosthesis on endosseous implants in the maxilla or mandible to restore chewing function. These custom-made titanium or titanium alloy devices feature a scalloped cuff that matches natural soft-tissue contours.
Indications and Contraindications
Indications for Use
Practitioners use anatomic/cosmetic abutments as single-unit components for cement-retained crowns.
Contraindications
Do not use dental implant abutments in patients who:
Are medically unfit for dental implant procedures.
Have a hypersensitivity or allergy to titanium or titanium alloys.
Lack adequate bone for enough implants to support a prosthesis.
Clinical Safety Guidelines
Warnings for Practitioners
These instructions do not replace formal training. Improper technique may cause implant failure, nerve damage, or bone loss. The practitioner is responsible for patient selection and informed consent.
General Cautions
Practitioners should use caution with smokers or patients with uncontrolled diabetes, steroid therapy, or previous radiation therapy.
Installation and Maintenance Procedures
Seating Cement-Retained Restorations
Remove the temporary restoration.
Verify the seating of the abutment.
Re-tighten the screw if applicable.
Seal the screw access hole with silicone.
Cement the final crown using conventional procedures.
Remove all excess cement from the margin.
Seating Screw-Retained Restorations
Attach the final restoration (crown and abutment) to the implant.
Verify the seating of the restoration.
Tighten the screw to the required torque.
Caution: Do not exceed the recommended tightening torque, as overtightening may cause screw fracture.
MRI Safety Information
The safety of this device in the Magnetic Resonance (MR) environment is unknown. Dental implant abutments have not been tested for heating, migration, or image artifacts. Scanning a patient with this device may result in injury.
Storage and Sterilization
Sterility: Abutments are supplied non-sterile and are for single use only.
Storage: Store the device in a dry, well-ventilated area at room temperature.
Protection: Keep the product out of direct sunlight to maintain device characteristics.
Disposal Guidelines
Used Abutments
Dispose of any component used in a patient's mouth as biological or medical waste. Follow all local and federal health regulations for biohazard management.
Unused Abutments
Unused titanium or zirconia abutments that have not touched bodily fluids may be disposed of as general waste, depending on local regulations.