TREPAN. INTERNAL DIAMETER 3.0 MM - Helmut Zepf (08.911.30)

What is the Helmut Zepf 3.0 mm trephine?

The Helmut Zepf trephine (reference 08.911.30) is a precision rotary instrument designed for bone surgery. This device features an internal diameter of 3.0 mm, allowing for the harvesting of bone cores with calibrated dimensions. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this instrument is delivered non-sterile and requires a complete cleaning, disinfection, and sterilization protocol before its first use as well as between each patient. Its structure is optimized to provide a clean cut during the drilling phases in oral surgery.

What are the clinical indications for the 3mm surgery trephine?

This 3mm surgery trephine is indicated for interventions requiring a circular excision of hard tissues. In clinical practice, it is used by dental surgeons and implantologists for autogenous bone harvesting, creating access wells, or removing root fragments and implants. Its use is common in bone grafting protocols or during the preparation of specific sites in implant surgery. The instrument is classified as a manual dental instrument intended exclusively for healthcare professionals trained in these technical acts.

What are the technical characteristics of this dental trephine drill?

The Helmut Zepf dental trephine drill is distinguished by its precise internal diameter of 3.0 mm, corresponding to technical reference 08.911.30. It belongs to Class I according to medical device regulations. Its medical stainless steel design guarantees compatibility with standard thermal and chemical reprocessing cycles. Due to its design and the materials used, the manufacturer Helmut Zepf Medizintechnik GmbH specifies that there is no defined maximum limit for treatment cycles, as long as the instrument shows no visible damage, cracks, or defects on the cutting edges.

What are the contraindications for the use of this trephine?

The main contraindication related to the use of this Helmut Zepf instrument is known hypersensitivity or intolerance to metals, specifically to the medical stainless steel composing the device. A hypersensitivity reaction can be triggered upon contact with the patient. If such a reaction occurs during the surgical act, the procedure must be immediately stopped and necessary medical measures must be taken. It is imperative to check the patient's allergic history before any intervention with this type of rotary instrument.

What are the maintenance and reprocessing precautions?

Like any non-sterile Class I instrument, this trephine must imperatively be cleaned, disinfected, and sterilized before the first use. Before each subsequent use, the practitioner must meticulously inspect the product to detect any visible damage such as cracks, breakages, or wear of the sharp edges. The use of damaged or worn products is strictly prohibited to guarantee patient safety and the effectiveness of the surgical gesture. Compatibility with other devices used simultaneously must also be verified beforehand by the professional.

Who is the manufacturer and what standards are respected?

The device is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with the regulatory requirements applicable to Class I medical devices (Class Ir according to the MDC0483 mention associated with the technical text). The product is identified under reference 08.911.30. As a Class I device, it meets the safety and performance standards imposed for manual dental instruments. Following the cleaning and sterilization instructions issued by Helmut Zepf is essential to maintain the compliance of the device throughout its life cycle.

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