Dental Mouth Opener DENHART 11 cm - Helmut Zepf (37.271.12) - Delynov

What is the DENHART 11 cm mouth opener - Helmut Zepf?

The DENHART mouth opener of 11 cm, referenced under code 37.271.12 at Delynov, is a specialized manual instrument designed for dental and oral surgery. Manufactured by Helmut Zepf Medizintechnik GmbH, this surgical mouth retractor is crafted from high-quality medical stainless steel to ensure optimal resistance during clinical procedures. Its mechanical structure allows the patient's jaws to be held in an open position in a fixed and secure manner, thereby offering increased visibility of the surgical site. This instrument is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use as well as between each patient, in accordance with the manufacturer's guidelines.

What are the clinical indications for this dental surgery mouth opener?

The use of this denhart mouth opener is primarily indicated during oral, maxillofacial, or implant surgery procedures requiring prolonged and stable access to the oral cavity. It is particularly useful for interventions in the posterior sectors or when the patient has difficulty maintaining a constant voluntary opening. As a manual dental instrument, it serves to retract the dental arches without major obstruction for the surgeon. Its use is strictly reserved for qualified healthcare professionals who must ensure the compatibility of the instrument with other devices used during the surgical act.

What are the technical characteristics of the 37.271.12 mouth opener?

This instrument from the Helmut Zepf brand has a total length of 11 cm, a compact dimension adapted to standard oral anatomy while providing sufficient leverage for effective opening. It is manufactured from medical stainless steel, a material chosen for its durability and its ability to undergo repeated reprocessing cycles. The device belongs to Class I according to the classification of medical devices. Its mechanical design is studied to minimize bulk while maximizing stability. Before each use, the practitioner must imperatively inspect the instrument to detect any visible damage, such as cracks, breaks, or defects on the edges, in order to guarantee patient safety.

What are the contraindications for the use of this instrument?

The main medical contraindication documented by the manufacturer Helmut Zepf concerns intolerance or hypersensitivity to metals. Since the instrument is composed of medical stainless steel, contact with the patient's tissues may trigger an allergic reaction in sensitive individuals. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately stopped and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before using this surgical buccal retractor. Additionally, it must never be used if signs of wear or structural damage are identified during the preoperative inspection.

What are the maintenance and sterilization precautions?

All instruments supplied by Helmut Zepf Medizintechnik GmbH are delivered non-sterile. A rigorous protocol of cleaning, disinfection, and sterilization is mandatory before the first use and after each subsequent use. It is essential to clean each product to remove any residue before the sterilization cycle. Due to the design of the mouth opener and the materials used, the manufacturer specifies that there is no defined maximum limit for the number of achievable processing cycles, as long as the instrument does not show signs of degradation. The use of damaged or worn products is formally prohibited to avoid any risk of breakage or injury during surgery.

Who is the manufacturer and what standards are respected?

The Denhart mouth opener is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This recognized manufacturer complies with the regulatory requirements for Class I medical devices. The instrument is designed to meet the specific needs of dental surgeons and implantologists. Traceability and manufacturing quality are ensured by the rigorous processes of Helmut Zepf, guaranteeing that each medical stainless steel instrument meets safety standards for professional use. Compliance with the instructions for use and safety provided by the manufacturer is essential to maintain the integrity of the device and ensure patient safety during surgical interventions.

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