Alpha Bio Bone Fixation Screw System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063769 FDA 510(k)
- FDA Product Code
- DZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4880 FDA 510(k)
- Regulation Number
- 872.4880 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Alpha Bio Bone Fixation Screw System is an intraosseous fixation device designed for stabilizing bone grafts, bone filling materials, and barrier membranes within the oral cavity. Classified as a screw fixation device (product code DZL), it is intended for use in dental procedures to support bone regeneration by securing materials in place during surgical interventions.
This system is supplied as a sterile, single-use device and includes titanium screws with diameters of 1.2 mm and 1.6 mm, along with a drill instrument for precise placement. It is regulated under FDA 510(k) clearance (K063769) and falls under Class II special controls for dental devices. The system is intended for use in controlled clinical settings, such as dental offices or oral surgery clinics, and must be stored according to manufacturer guidelines to maintain sterility.
Frequently asked questions
What is the Alpha Bio Bone Fixation Screw System used for?
This system is designed for intraosseous fixation in dental procedures to stabilize bone grafts, bone filling materials, and barrier membranes within the oral cavity. It helps secure these materials in place during surgery to support bone regeneration, ensuring proper integration and healing.
How is the Alpha Bio Bone Fixation Screw System supplied?
The system is supplied as a sterile, single-use device. It includes titanium screws in two diameters (1.2 mm and 1.6 mm) along with a drill instrument for precise placement. This ensures sterility and reduces the risk of cross-contamination between patients.
Are the screws reusable or intended for single-use?
The screws are explicitly intended for single-use only. This design choice maintains sterility and hygiene standards, which are critical in clinical settings like dental offices or oral surgery clinics to prevent infection and ensure patient safety.
What sizes of screws are available in this system?
The Alpha Bio Bone Fixation Screw System provides titanium screws in two standard diameters: 1.2 mm and 1.6 mm. These sizes are chosen to accommodate various clinical needs for bone fixation in oral and maxillofacial procedures.
How should the Alpha Bio Bone Fixation Screw System be stored?
The system must be stored according to the manufacturer’s guidelines to preserve sterility. Proper storage conditions typically include a clean, dry environment, away from direct sunlight or extreme temperatures, and in the original packaging until ready for use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K063769 FDA 510 (k) - ALPHA BIO BONE FIXATION SCREW SYSTEM, ALPHA BIO BONE FIXATION SCREW SYSTEM - Innolitics, Alpha - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063769 | Class II | Active |
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Manufacturer
- Manufacturer
- Alpha Bio Tec Ltd.
- FDA Applicant
- Alpha-Bio Tec , Ltd.
Sources (1)
- FDA 510(k) K063769 24 fields · synced Oct 1, 2026