Scalpel 2 / 2.2 mm - Helmut Zepf (47.099.31) - Delynov

What is the Helmut Zepf 2 / 2.2 mm spacer?

The Helmut Zepf 2 / 2.2 mm spacer, referenced under code 47.099.31, is a dental surgery accessory designed for drilling depth management. This device, manufactured by Helmut Zepf Medizintechnik GmbH, is presented as a removable drill stop. It is designed in high-quality medical stainless steel to meet the requirements of oral surgery. As a manual instrument, it is integrated into the implant preparation protocol to offer additional safety to the practitioner during the creation of the implant site, avoiding any unwanted exceeding of the planned drilling length.

What are the clinical indications for this accessory?

This surgical measurement spacer is primarily indicated during drilling phases in implantology and bone surgery. Its role is to serve as a guiding spacer and depth control for drills of corresponding diameters (2 mm and 2.2 mm). It is used to secure the osteotomy, particularly in high-risk areas where proximity to the inferior alveolar nerve or maxillary sinus requires millimeter precision. It helps the surgeon maintain a constant and reproducible depth throughout the intervention, thus ensuring compliance with the pre-operative treatment plan established by imaging.

What are the technical characteristics of the 47.099.31 spacer?

The Helmut Zepf dental thickness spacer features specific technical characteristics for perfect integration with compatible rotary instruments. It possesses a double calibration of 2 mm and 2.2 mm, corresponding to the standards of pilot drills used at the start of the implant sequence. Manufactured in medical stainless steel, it is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH. Its design allows for repeated sterilization without alteration of its physical properties. As a Class I device, it meets the basic safety requirements for reusable manual surgical instruments, although the maximum number of processing cycles is not defined by a strict limit.

What are the contraindications for the use of this device?

The main medical contraindication mentioned by the manufacturer concerns known hypersensitivity or intolerance to metals. As the instrument is manufactured from medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive subjects. If such a hypersensitivity reaction occurs during the surgical procedure, the procedure must be immediately stopped and the necessary clinical measures must be taken. Apart from this material-related contraindication, the use of this device is strictly reserved for qualified healthcare professionals mastering implant and oral surgery protocols.

What are the maintenance and sterilization precautions?

As a non-absorbable and reusable device, a rigorous reprocessing procedure is mandatory. Before the first use and after each subsequent use, the spacer must be cleaned, disinfected, and sterilized according to current protocols. It is imperative to visually inspect the product before each intervention to detect any potential damage or signs of wear, such as cracks, breaks, or defects on the contact surfaces. Any instrument that is damaged or shows signs of visible wear must never be used. Compatibility with other instruments in the drilling sequence must also be systematically checked before the start of surgery.

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 medical device according to current regulations. The manufacturer specifies that the products are delivered non-sterile and must undergo a complete cleaning and sterilization cycle before any clinical use. As a manual dental instrument, it is designed to meet the quality standards of the German medical industry. Compliance with the instructions for use and safety provided by Helmut Zepf is essential to guarantee the performance of the device and patient safety during dental surgery interventions.

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Surgical medical consumables play a decisive role in operative safety.