OBS Anchorage Screw

The OBS Anchorage Screw is designed for temporary skeletal anchorage in orthodontic treatment, providing a stable reference point within the bone. It functions as a self-drilling, self-tapping implant that allows precise application of orthodontic forces, facilitating controlled tooth movement. This is particularly useful in cases requiring complex corrections, such as space closure, intrusion, or extrusion of teeth, where traditional anchorage methods may be insufficient.

The OBS Anchorage Screw is explicitly supplied as a single-use, sterile implant. To maintain sterility, it must be handled using aseptic techniques, opened only in a sterile field, and used immediately after removal from its packaging. Proper storage in a clean, dry environment, away from direct sunlight or extreme temperatures, is also essential to preserve its sterility and integrity before use.

The OBS Anchorage Screw comes in multiple sizes, as indicated by the registration numbers listed (e.g., 3009732568, 3008323540, etc.). The appropriate size depends on the patient’s bone density, anatomical location, and the specific orthodontic requirements. Clinicians should consult the manufacturer’s sizing guidelines or product documentation to select the correct screw diameter and length based on these factors, ensuring optimal stability and integration with the bone.

The OBS Anchorage Screw should be stored in its original, sealed packaging in a clean, dry environment protected from moisture, dust, and extreme temperatures. The manufacturer does not specify a shelf life in the provided data, but standard medical device storage practices—such as avoiding exposure to direct sunlight or humidity—should be followed. Always verify sterility indicators on the packaging before use, and adhere to the facility’s protocol for sterile instrument storage.

The OBS Anchorage Screw has received FDA 510(k) clearance and compliance with the MDD (Medical Device Directive), confirming it meets regulatory standards for orthodontic implants in the U.S. and EU markets. This clearance indicates that the device has been evaluated for safety and effectiveness by the FDA and is classified as Class II, requiring special controls but not pre-market approval. Clinicians can use it with confidence, provided they follow the manufacturer’s instructions for use and adhere to standard orthodontic practices.