An Endosseous Dental Implant is a pre-manufactured, root-form implant fixture intended to be surgically placed into the jawbone to provide support for a dental prosthesis such as a crown, bridge, or overdenture. The device functions as an artificial tooth root and serves as the structural foundation for an abutment and subsequent prosthetic restoration. Once implanted, the device is designed to integrate with the surrounding bone (osseointegration) to provide long-term stability and load-bearing support for chewing function. It is commonly referred to as a Dental Implant Fixture, Implant Body, Implant Screw, or Endosseous Implant.

Intended Use of Endosseous Dental Implant

An Endosseous Dental Implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, to restore a patient’s chewing function.

It is intended to be implanted in the upper or lower jaw arches to provide a root-form means for single or multiple unit prosthetic attachment and to restore chewing function. It is also intended for surgical placement in the maxillary or mandibular bone to provide support for prosthetic dental restorations, including single-tooth, multiple-tooth, or full-arch restorations, in order to restore chewing function.

The device may be placed using a one-stage or two-stage surgical approach and may be restored with immediate or delayed loading when sufficient primary stability is achieved, as determined by the clinician.

Device Description:

An Endosseous Dental Implant is a threaded, screw-type or cylindrical implant intended for placement within the jawbone to function as an artificial tooth root.The implant is typically manufactured from commercially pure titanium or titanium alloy and is available in various diameters and lengths to accommodate patient anatomy.

Key characteristics generally include:

• Tapered or cylindrical body design
• External thread pattern for primary stability
• Surface treatment (e.g., machined, sandblasted, acid-etched) to support osseointegration
• Internal prosthetic connection geometry (e.g., internal hex or conical connection)
• Compatibility with prosthetic components such as abutments, healing caps, and cover screws

The implant is typically provided sterile and is intended for single use only.

Blade-Form Endosseous Dental Implant

Intended Use:

The Blade-Form Endosseous Dental Implant is intended for surgical placement in the maxillary or mandibular bone to provide support for dental prostheses, including single-tooth, multiple-tooth, or full-arch restorations, in order to restore chewing function.

Device Description:

The Blade-Form Endosseous Dental Implant System consists of an implant designed to be surgically placed within the jawbone (maxilla or mandible) to serve as a stable foundation for dental prostheses.

The implant is typically manufactured from commercially pure titanium or titanium alloy and features a blade-form body that is inserted into a surgically prepared slot in the bone. The design provides primary mechanical stability through its geometry and engages bone laterally.

Implant, Endosseous, Orthodontic

Intended Use:

The Endosseous Orthodontic Implant is intended for temporary surgical placement in the maxillary or mandibular bone to provide skeletal anchorage for orthodontic appliances used to facilitate tooth movement during orthodontic treatment. The device is intended to be removed following completion of orthodontic treatment.

Device Description:

The Endosseous Orthodontic Implant is a temporary anchorage device designed for placement in the alveolar bone of the maxilla or mandible. The device is typically manufactured from titanium or titanium alloy and is provided in various diameters and lengths to accommodate different anatomical requirements. The device is intended for temporary use and is removed after orthodontic correction is achieved. The implant is typically supplied sterile and intended for single use only.

The implant generally consists of:

• A threaded screw-type body to facilitate primary mechanical stability
• A transmucosal neck region
• A head portion designed to engage orthodontic appliances (e.g., elastics, wires, springs)
• Surface finish that may be machined or surface-treated to support mechanical retention

Performance Testing of Endosseous Dental Implant

• Insertion Torque Testing
• Pull-Out Strength
• Static Mechanical Strength
• Torsional Strength
• Fatigue Testing (If Load bearing > Short-Term)
• Dimensional Verification
• Static compression strength
• Bending strength
• Torsional strength
• Fatigue testing (ISO 14801 – Dental implant fatigue test)
• Abutment-implant connection testing
• Dynamic cyclic fatigue
• Interface micromovement testing (if novel connection)
• Bending strength
• Static compression
• Fatigue testing (modified ISO 14801 setup depending on design)
• Pull-out strength
• Worst-case configuration testing
• Lateral load performance
• Biocompatibility (ISO 10993)
• Sterilization & Shelf Life

Clinical Testing:

No Guidance available for 510k submission