Difficult to Turn Blade for Benex - Helmut Zepf (12.300.45) - Delynov
The Lame à tourner pour Benex - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 12.300.45.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the turning blade for Benex - Helmut Zepf (12.300.45)?
The turning blade for Benex, referenced under code 12.300.45, is a specific component designed by Helmut Zepf Medizintechnik GmbH. It is a benex spare part intended to maintain the efficiency of the brand's root extraction system. Manufactured from medical stainless steel, this blade is structured to meet the mechanical constraints of vertical extraction. As a manual instrument, it belongs to Class I of medical devices. Its design allows for precise manipulation during the preparatory stages of extraction, ensuring that the dental root extractor functions according to the performance standards set by the manufacturer.
What are the clinical indications for this blade?
This benex extraction blade is indicated for oral surgery procedures requiring atraumatic dental extraction, particularly when the preservation of the vestibular bone plate is critical for future implantation. It is used to prepare the site before using the Benex dental root extractor, allowing for the release of ligamentous attachments or creating a favorable space for anchoring the traction screw. Its use is strictly reserved for qualified healthcare professionals operating in contexts of fractured root extractions or teeth where the coronal structure is absent or too decayed for traditional forceps.
What are the technical characteristics of this spare part?
The benex extractor blade is characterized by its technical reference 12.300.45 within the Helmut Zepf catalog. Designed in medical stainless steel, it exhibits high resistance to corrosion and repeated sterilization cycles. This device is delivered non-sterile by Helmut Zepf Medizintechnik GmbH and must undergo a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient. Its geometry is specifically adapted to the rotation mechanism of the Benex system, ensuring perfect compatibility and optimal force transmission without damaging the body of the main instrument.
What are the contraindications for the use of this instrument?
The main medical contraindication documented by the manufacturer Helmut Zepf concerns known hypersensitivity or intolerance to metals, specifically the medical stainless steel used for the manufacture of the blade. In the event of an allergic reaction or hypersensitivity triggered during the procedure, the procedure must be immediately interrupted and necessary clinical measures must be taken. Furthermore, the use of this dental extractor spare part is prohibited if the instrument shows visible damage such as cracks, breaks, or defects on the cutting edges, to prevent any risk of intraoperative rupture.
What are the maintenance and reprocessing precautions?
The reprocessing of the benex blade must follow strict safety instructions. Before any use, the practitioner must check for the absence of wear or visible damage. Due to its design and the materials used, there is no defined maximum limit for treatment cycles, but vigilance regarding the state of the cutting edges is paramount. Cleaning must be complete before sterilization. It is crucial to verify compatibility with other products of the Benex system before the surgical act. The use of worn or damaged instruments is formally prohibited by Helmut Zepf to guarantee patient safety and extraction efficiency.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This product is classified as a Class I manual dental instrument according to current regulations. Although the specific CE marking is not detailed in the provided sources, the manufacturer complies with rigorous manufacturing protocols related to medical stainless steel (MDC0483). As a Class I device, it meets the essential safety and performance requirements for non-invasive or invasive surgical instruments for temporary use, guaranteeing consistent industrial quality for dental surgeons and implantologists.
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Specifications
| Manufacturer | Helmut Zepf |
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