S1

The S1 Bone Grafting Material is designed to promote bone regeneration and healing in dental procedures requiring bone augmentation. It acts as a scaffold for new bone formation, which is particularly useful in procedures like ridge preservation, sinus lifts, or extraction socket grafts where bone volume needs to be restored or maintained before implant placement.

The S1 Bone Grafting Material is supplied in a sterile form and is explicitly intended for single-use applications within dental settings. This ensures patient safety and maintains sterility, as reuse could compromise its integrity and risk infection.

The S1 Bone Grafting Material is supplied in multiple lot-specific reference codes (e.g., 3009598981, 3011649314, etc.), which are tied to its regulatory registration. When ordering, ensure you select the correct lot code for traceability and compliance, as each lot may have unique batch details. The product is sterile and ready for immediate use in dental procedures.

The S1 Bone Grafting Material is regulated under the FDA’s 510(k) pathway (traditional clearance, determined as *Substantially Equivalent* to a predicate device) and the Medical Device Directive (MDD). This means it has undergone a formal review process to ensure safety and effectiveness for its intended use in dental bone augmentation. Clinicians should confirm the product’s compliance with these regulations when procuring or using it.

While the provided data does not explicitly detail storage conditions, the material is sterile and intended for single-use. As with most sterile medical devices, it should be stored in a clean, dry environment, protected from contamination, and used within the manufacturer’s specified shelf life (if applicable). Always refer to the accompanying packaging instructions for precise storage guidance.