Combination Instrument - Helmut Zepf (46.035.15) - Delynov

What is the Helmut Zepf 46.035.15 combination instrument?

The Helmut Zepf combination instrument, bearing reference 46.035.15, is a manual instrument specifically designed for dental health professionals. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this device belongs to the category of combined surgical instruments. Its robust structure allows for repeated use after a strict sterilization protocol. It is classified as a Class I medical device, ensuring its compliance with regulatory requirements for non-invasive or invasive instruments for temporary use in dental practices.

What are the clinical indications for this instrument?

This dental combination instrument is indicated for use during clinical examinations and oral surgery interventions. As a combined periodontal probe, it is primarily used for tissue exploration, measuring periodontal pocket depths, and evaluating structures during pre-implant assessments. Its use is strictly reserved for qualified healthcare professionals working in periodontal care, oral surgery, or implantology contexts to facilitate diagnosis and treatment monitoring.

What are the technical characteristics of this instrument?

The Helmut Zepf 46.035.15 instrument is manufactured from high-quality medical stainless steel. This material is chosen for its resistance to cleaning and sterilization cycles. The device is delivered non-sterile and must undergo complete processing before its first use. Its design allows for multiple reprocessing, although no maximum cycle limit is defined by the manufacturer, as this depends on visible wear, the appearance of cracks, or defects on the active parts of the instrument.

What are the contraindications for the use of this instrument?

The main contraindication for the use of this instrument is the patient's known hypersensitivity or intolerance to metals, and specifically to the components of medical stainless steel. If a hypersensitivity reaction is triggered upon contact with the instrument, the procedure must be stopped immediately and necessary medical measures must be taken. It is the practitioner's responsibility to check the patient's allergic history before any intervention with this manual instrument.

What are the maintenance and safety precautions?

All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to inspect the instrument before each intervention to detect any visible damage such as cracks, breaks, or defects on the edges. The use of a damaged or worn product is prohibited. Reprocessing must follow standard hospital or dental practice sterilization protocols to ensure patient safety and the longevity of the stainless steel device.

Who is the manufacturer and what standards are respected?

The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with medical device manufacturing standards to ensure the safety and reliability of its products. The instrument is listed as a Class I medical device according to current regulations. As a product distributed by Delynov, it meets the quality requirements expected by dental surgeons and implantologists for their daily practice in oral surgery.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.