Short screwdriver, Dental shaft - Helmut Zepf (47.832.03)
The TOURNEVIS COURT, TIGE DENTAIRE - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 47.832.03.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the SHORT SCREWDRIVER, DENTAL SHAFT - Helmut Zepf (47.832.03)?
The short screwdriver with reference 47.832.03 is a manual instrument developed by Helmut Zepf Medizintechnik GmbH. Designed specifically for the needs of oral surgery, this device belongs to the category of guided bone regeneration (GBR) instruments. Its structure consists of a main body and a dental shaft adapted for precision handling. Manufactured from medical stainless steel, this instrument meets the durability and resistance requirements necessary in a clinical environment. As a Class I device, it is intended for strict professional use by qualified practitioners in implantology or oral surgery.
What are the clinical indications?
This Helmut Zepf manual instrument is indicated for all procedures requiring the use of a short screwdriver during dental interventions. It is mainly used in the context of placing fixation devices or prosthetic components in implant and periodontal surgery. Its use is intended for manual manipulation, allowing the surgeon to exercise direct control during tightening or loosening. It integrates perfectly into bone regeneration protocols where the workspace may be limited, requiring a compact tool to secure reconstruction elements.
What are the technical characteristics of this screwdriver?
The Helmut Zepf screwdriver (reference 47.832.03) is distinguished by its short design, optimizing ergonomics in posterior or difficult-to-access areas. It features a dental shaft compatible with the brand's standards to ensure adequate force transmission. The material used is a medical-grade stainless steel, selected for its biocompatibility and its ability to withstand repeated cleaning and sterilization cycles. This device is delivered non-sterile by the manufacturer and must undergo a complete decontamination protocol before its first use and between each patient.
What are the contraindications for use?
The main contraindication related to the use of this Helmut Zepf instrument concerns known hypersensitivity or intolerance to metals, specifically medical stainless steel. If an allergic reaction or hypersensitivity reaction is triggered in the patient upon contact with the instrument, the procedure must be immediately interrupted. Appropriate clinical measures must then be taken. It is the responsibility of the practitioner to check the patient's allergic history before any intervention using this metallic instrument to prevent any undesirable side effects related to the material composition.
What are the maintenance and reprocessing precautions?
Like any reusable Class I instrument, this screwdriver requires rigorous maintenance. Before each use, the practitioner must perform a visual inspection to detect potential damage such as cracks, breaks, or defects on the active parts. Any worn or damaged product must never be used. The reprocessing process includes cleaning, disinfection, and full sterilization. Although no maximum cycle limit is defined due to its robust stainless steel design, compatibility with other cleaning and sterilization products must be verified beforehand to ensure the integrity of the instrument.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This screwdriver is classified as a Class I medical device (Class Ir according to specified MDR mentions). The manufacturer guarantees that its products are designed for professional use by qualified healthcare professionals. Compliance with regulatory requirements ensures that the instrument meets safety standards for manual dental interventions. Traceability is ensured by the reference code 47.832.03, allowing precise identification of the model within the brand's surgical range.
State of the art
Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.
Specifications
| Manufacturer | Helmut Zepf |
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