Long Tapered Single - Helmut Zepf (26.428.02) - Delynov
The Pointe longue seule - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.428.02.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf long tip alone (26.428.02)?
The long tip alone, referenced under code 26.428.02, is a manual instrument manufactured by Helmut Zepf Medizintechnik GmbH. Designed to be used as a syndesmotome tip, it is made of high-quality medical stainless steel to ensure its resistance during clinical interventions. This component is intended to be mounted on a compatible handle to perform precise movements in oral surgery. As a syndesmotome insert, its structure is optimized to fit into the desmodontal space. This device is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before each use in the dental office.
What are the clinical indications for this syndesmotome insert?
This instrument is indicated for dental and oral surgery procedures requiring the separation of the epithelial-connective attachment. The primary use of this Helmut Zepf long tip lies in syndesmotomy, an essential preliminary step to tooth extraction to limit alveolar trauma. It allows for the sectioning of the ligament fibers that hold the tooth in its socket. Its elongated profile is particularly suitable for reaching deep or difficult-to-access areas, thus facilitating the work of the implantologist or dental surgeon during the preparation of surgical sites or exodontia.
What are the technical characteristics of the 26.428.02 tip?
The Helmut Zepf long tip (reference 26.428.02) is characterized by its medical stainless steel composition, a standard material for surgical instrumentation ensuring durability through repeated sterilization cycles. It is a Class I device according to current regulations. Its specific "long tip" geometry allows for thin and precise insertion. The instrument is designed to be removable, allowing the practitioner to replace only the syndesmotome insert on its instrument handle. No maximum use cycle is defined by the manufacturer Helmut Zepf Medizintechnik GmbH, as wear depends on the frequency and conditions of use.
What are the contraindications for using this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns hypersensitivity or intolerance to metals. Since the instrument is manufactured from medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the intervention, the procedure must be stopped immediately and the necessary medical measures must be taken. It is therefore imperative to question the patient about their allergic history before any manipulation with this insert.
What are the maintenance and reprocessing precautions?
Like any non-resorbable and reusable oral surgery instrument, this Helmut Zepf tip must follow a strict protocol. Before the first use and after each subsequent use, the instrument must be cleaned, disinfected, and sterilized. The practitioner must perform a rigorous visual inspection to detect any damage such as cracks, breaks, or wear of the cutting edges. It is strictly forbidden to use a damaged product. Reprocessing must comply with the manufacturer's safety instructions to maintain the integrity of the stainless steel. Compatibility with other products in the surgical arsenal must also be verified beforehand.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This product is classified as a Class I manual dental instrument. In accordance with regulatory requirements, the manufacturer provides instructions regarding the intended purpose, warnings, and reprocessing. Although the specific CE marking is not detailed in the source data, the product meets the manufacturing standards for medical stainless steel required for professional instrumentation. This device is exclusively reserved for use by healthcare professionals qualified in dental surgery.
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Specifications
| Manufacturer | Helmut Zepf |
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