Small composite filling set - Helmut Zepf (26.120.01TI) - Delynov
The Jeu de composite petit - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.120.01TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the small Helmut Zepf composite set?
The small composite set from the brand Helmut Zepf, referenced under code 26.120.01TI at Delynov, is a set of manual instruments specifically developed for conservative dentistry. Manufactured by Helmut Zepf Medizintechnik GmbH, this device is designed in high-quality medical stainless steel to guarantee optimal handling of composite materials. As a Class I instrument, it meets the regulatory requirements for non-invasive or short-term invasive devices. Its structure is designed to offer a precise tactile response during the modeling of direct restorations, allowing the practitioner to sculpt materials with great fluidity.
What are the clinical indications for these dental composite spatulas?
This dental composite spatula set is indicated for all conservative dentistry interventions requiring the working of restorative materials on the tooth. Its primary use concerns the application, placement, and modeling of restorative composites. Thanks to its ergonomic design, it facilitates the shaping of cavity walls and occlusal surfaces. The manufacturer's official indication specifies that it is a manual dental instrument used to work on the tooth. It is particularly suitable for small cavities or restricted access areas where fine instrumentation is required to ensure the aesthetic and functional integration of the restoration.
What are the technical characteristics of reference 26.120.01TI?
Technical reference 26.120.01TI corresponds to a small-sized composite set manufactured by Helmut Zepf Medizintechnik GmbH. The instruments are crafted from a medical stainless steel selected for its resistance and compatibility with hospital sterilization protocols. Although delivered non-sterile, these instruments are designed to withstand repeated cycles of cleaning, disinfection, and sterilization without alteration of their mechanical properties. The manufacturer indicates that due to the product design and the materials used, there is no defined maximum limit for the number of processing cycles, as long as the instrument does not show visible damage.
What are the contraindications for the use of this instrument?
The main contraindication related to the use of this Helmut Zepf composite set is known hypersensitivity or intolerance to metals in the patient. Since the instrument is composed of medical stainless steel, direct contact can trigger an allergic reaction in sensitive subjects. The manufacturer warns that if such a hypersensitivity reaction occurs during the intervention, the procedure must be stopped immediately and the necessary medical measures must be taken. It is therefore crucial to assess the patient's allergic history before any use. Furthermore, use is strictly reserved for qualified healthcare professionals proficient in conservative dentistry techniques.
What maintenance and safety precautions must be observed?
All instruments in the composite set must imperatively be cleaned, disinfected, and sterilized before the very first use, as well as after each subsequent use. Strict compliance with these protocols is essential to prevent risks of cross-contamination. Before each intervention, the practitioner must visually inspect the instrument to detect any damage or signs of wear, such as cracks, breaks, or defects on the cutting edges. It is formally forbidden to use a damaged or worn product. Compatibility with other products used during treatment must also be verified beforehand to ensure patient safety and care effectiveness.
Who is the manufacturer and what standards are met by this device?
This medical device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. The product is classified as a Class I medical device according to current regulations. As the official manufacturer, Helmut Zepf guarantees that its instruments are produced according to strict quality standards to meet the needs of healthcare professionals. The instructions for use emphasize the importance of systematic reprocessing and monitoring the condition of the instruments. This composite set is exclusively intended for professional use in dental offices or clinical settings, ensuring full compliance with safety requirements for conservative treatments.
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| Manufacturer | Helmut Zepf |
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