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3mm Titanium Pins - Helmut Zepf (47.560.03) - Delynov

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Product features

The x5 Pin's en Titane de 3mm - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.

  • Compliance: Medical device Class IIb.
  • Manufacturer: Helmut Zepf Medizintechnik GmbH.
  • Intended use: Device for guided bone regeneration (GBR), indicated for the reconstruction of bone defects in pre-implant and peri-implant surgery.
  • Reference: 47.560.03.
  • Reserved for healthcare professionals. Read instructions carefully before use.

fabricant : HELMUT ZEPF Medizintechnik Gmbh , Obere Hauptstraße 16-22, D- 78606 Seitingen-Oberflacht BUT PRÉVU / INDICATION Les broches en titane sont destinées au traitement ostéosynthétique des défauts de crête en dentisterie. La broche en titane est enfoncée dans l'os pour fixer les membranes ou les mailles en titane insérées afin d'isoler l'os des tissus mous gingivaux pendant la régénération et/ou pour fixer l'os augmenté/substitut osseux en matériau osseux autologue/allogène ou un mélange. Les effets secondaires indésirables l'intolérance aux métaux chez le patient peut résulter d'un contact avec l'instrument, qui est en acier inoxydable médical une réaction d'hypersensibilité était toujours déclenchée devenir. la procédure doit être arrêtée si une telle réaction se produit et les mesures nécessaires sont prises en conséquence. consignes d'utilisation et de sécurité tous les instruments doivent être nettoyés avant d'être utilisés pour la première fois et compléter avant toute utilisation ultérieure nettoyé, désinfecté et stérilisé ! il est très important de nettoyer chaque produit avant utilisation dommages et usures visibles, par ex. b. fissures, cassures ou des défauts sur les arêtes de coupe. n'utilisez jamais de produits endommagés ou usés. les produits de helmut zepf medizintechnik gmbh sont livrés non stériles. les produits doivent être à l'avance nettoyé et stérilisé. la compatibilité aussi les autres produits doivent être vérifiés au préalable. retraitement en raison de la conception du produit, des matériaux utilisés et il ne peut y avoir de limite maximale définie pour l'utilisation prévue des cycles de traitement réalisables peuvent être déterminés.réservé aux professionnels de santé.

Medical devices intended for healthcare professionals. Classes I, II and III. Carefully read the instructions in the leaflets and user manuals.

76.20 € 76.2 EUR 76.20 € Tax Included 115.29 €

76.20 € Tax Included 115.29 €

(0.00 € / Units)
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GBR

What is the pack of x5 3mm Titanium Pin's from Helmut Zepf?

The pack of x5 3mm Titanium Pin's, referenced under code 47.560.03 by Helmut Zepf, is a medical device designed for osteosynthetic fixation during bone regeneration procedures. These titanium pins are specifically structured to hold surgical membranes or meshes in place. Their robust design allows for precise insertion into the bone, ensuring optimal stability of the barrier material. As high-precision instruments developed by Helmut Zepf Medizintechnik GmbH, these pins facilitate the isolation of the regeneration zone from the gingival soft tissues, thus guaranteeing a favorable environment for bone formation without mechanical interference.

What are the clinical indications for these titanium pins?

Helmut Zepf titanium pins are indicated for the osteosynthetic treatment of ridge defects in dentistry and oral surgery. They are primarily used to drive in and fix titanium membranes or meshes inserted to isolate the bone from the gingival soft tissues during the regeneration phase. Additionally, these devices are intended for the fixation of augmented bone or bone substitutes, whether autologous, allogeneic materials, or composite mixtures. Their role is crucial for stabilizing the filling material and the protective membrane, allowing for predictable reconstruction of bone volume before implant placement or for the correction of complex periodontal defects.

What are the technical characteristics of this device (ref. 47.560.03)?

This medical device, identified by technical reference 47.560.03, consists of five pins with a length of 3mm manufactured from high-quality titanium. Although the pins are made of titanium, it is important to note that the associated instrumentation for their handling may be made of medical stainless steel. These products are delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH. Consequently, a complete cleaning, disinfection, and sterilization procedure is imperative before the first use and between each subsequent cycle. The product design does not define a maximum limit for processing cycles, but a rigorous visual inspection is necessary to detect any cracks, breaks, or wear of the cutting edges before each intervention.

What are the contraindications for the use of these titanium pins?

The main contraindication for the use of these devices lies in the patient's known hypersensitivity or intolerance to metals. An allergic reaction can be triggered either by the titanium of the pin or by the medical stainless steel of the placement instrument. If a hypersensitivity reaction occurs during the intervention, the procedure must be immediately interrupted and appropriate medical measures must be taken. It is also prohibited to use products with visible damage such as cracks or structural defects. The use of these devices is strictly reserved for qualified healthcare professionals mastering oral surgery and guided bone regeneration techniques.

What are the precautions for use and safety instructions?

Helmut Zepf titanium pins are non-resorbable devices that require rigorous handling. Before any use, the practitioner must verify compatibility with other surgical instruments. All products must undergo complete reprocessing (cleaning and sterilization) before being put into service. It is essential never to use damaged or worn products. During the healing phase, the stability of the pins must be monitored to ensure they continue to effectively maintain the membrane or bone substitute. Due to their metallic nature, they do not undergo degradation by hydrolysis and remain in place until their clinical removal or according to the regeneration protocol chosen by the surgeon.

Who is the manufacturer and what standards are respected?

These devices are manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This product is classified as a Class IIb medical device, meeting strict regulatory requirements for long-term or invasive surgical implants. The manufacturer guarantees compliance with safety standards for the treatment of ridge defects. Although the products are delivered non-sterile, they are designed to withstand repeated sterilization cycles without loss of defined mechanical properties, subject to adequate maintenance. Compliance with cleaning and sterilization protocols is the direct responsibility of the healthcare professional, in accordance with the instructions provided by Helmut Zepf.


State of the art

Guided bone regeneration (GBR) in implantology relies on membrane fixation quality and predictable bone consolidation.

Further reading on Delynov

Specifications

Manufacturer Helmut Zepf
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GBR