Titanium 5mm Brooch - Helmut Zepf (47.560.05) - Delynov

What is the Helmut Zepf 5mm titanium pin?

The 5mm titanium pin from Helmut Zepf, referenced under code 47.560.05, is a titanium membrane fixation device designed for oral surgery. Manufactured by Helmut Zepf Medizintechnik GmbH, this membrane fixation pin utilizes the mechanical properties of titanium to offer a rigid and biocompatible holding solution. Its 5mm structure is specifically adapted to anchor guided bone regeneration (GBR) membranes into the cortical bone, thereby ensuring that the filling material remains protected and immobile throughout the initial healing phase.

What are the clinical indications for this dental surgery titanium nail?

The use of this dental surgery titanium nail is indicated in alveolar reconstruction protocols requiring rigid dental membrane fixation. In implantology and periodontology, membrane stability is a critical success factor to prevent connective tissue invasion and allow osteogenesis. This pin is particularly requested during horizontal or vertical bone augmentations where the membrane must be maintained under tension against the bone defect. It is suitable for both resorbable and non-resorbable membranes, offering clinical versatility to secure the graft site.

What are the technical characteristics of reference 47.560.05?

Technical reference 47.560.05 corresponds to a titanium surgery pin with a length of 5mm. This dimension is calibrated to ensure sufficient penetration into the cortical bone while limiting bulk under the soft tissues. The Helmut Zepf design emphasizes tip precision to facilitate insertion and head geometry to ensure perfect seating of the membrane against the bone wall. The choice of titanium as the primary material guarantees excellent corrosion resistance and biological integration respectful of the surrounding tissues.

What are the contraindications for the use of this fixation pin?

Although raw MDR specifications are not detailed here, standard contraindications for a titanium surgery pin include patients with known allergies to titanium or its alloys. Its use is also discouraged in areas with insufficient bone density to ensure device anchorage, or in the presence of active untreated local infections at the surgical site. As with any invasive device, an assessment of the patient's general health status, particularly concerning healing disorders or systemic bone pathologies, is imperative before the procedure.

What are the precautions related to the non-resorbable nature of titanium?

This titanium surgery pin is composed of a non-resorbable material, meaning it retains its mechanical properties and structure indefinitely after placement. Depending on the clinical protocol chosen by the practitioner, a second intervention may be necessary to remove the pin once bone regeneration has consolidated. During placement, it is crucial to ensure that the head of the pin does not create an area of excessive tension under the mucoperiosteal flap to avoid any post-operative exposure. Radiological follow-up allows for verification of the membrane fixation maintenance during the healing phase.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer in the precision surgical instrumentation sector. Helmut Zepf is renowned for the quality of its manufacturing processes in Germany. Regarding specific certifications such as CE marking or the exact regulatory class of reference 47.560.05, this information is not specified in the current technical documentation. It is strongly recommended that practitioners consult the instructions for use and product labeling provided by Helmut Zepf to confirm compliance with current standards before any clinical use.

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