Spatula for Composite - Helmut Zepf (24.751.328TI) - Delynov
The SPATULE POUR COMPOSITE. - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.751.328TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf composite spatula (24.751.328TI)?
The composite spatula referenced 24.751.328TI is a high-precision manual instrument developed by Helmut Zepf Medizintechnik GmbH. This device is specifically structured for the manipulation of aesthetic restorative materials. Manufactured from medical-grade stainless steel, it offers rigidity suitable for working with composite resins. As an instrument in the CONSO category, it meets the durability requirements necessary for daily interventions in the practice. Its structure allows for a stable grip, essential for the fine modeling of occlusal and proximal surfaces during conservative treatments.
What are the clinical indications for this instrument?
The intended use of this Helmut Zepf manual instrument is strictly limited to dental care. It is primarily indicated for the transport, application, and modeling of restorative composites. In conservative surgery, this spatula allows for sculpting the material before its polymerization, thus ensuring optimal marginal adaptation. It can be used for Class I to V restorations, where the precision of the movement is decisive for the functional integration of the resin. Its use is reserved exclusively for qualified healthcare professionals mastering adhesive dentistry techniques.
What are the technical characteristics of the 24.751.328TI spatula?
The Helmut Zepf 24.751.328TI spatula is distinguished by its medical stainless steel construction, guaranteeing corrosion resistance during repeated sterilization cycles. This device belongs to Class I of medical devices. Although delivered non-sterile, it is designed to withstand cleaning, disinfection, and autoclave sterilization protocols. Its technical reference (24.751.328TI) guarantees precise product traceability. The design of the instrument does not define a maximum limit of processing cycles, as this depends on visible wear and the care taken during reprocessing by healthcare personnel.
What are the contraindications for using this instrument?
The main medical contraindication mentioned by the manufacturer Helmut Zepf concerns known hypersensitivity or intolerance to metals. Since the instrument is made of medical stainless steel, contact with the patient may trigger an allergic reaction in sensitive subjects. If such a hypersensitivity reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. It is therefore recommended to evaluate the patient's allergic history before any use. Furthermore, use is strictly prohibited if the instrument shows visible damage such as cracks or breaks.
What are the maintenance and safety precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is crucial to visually inspect the device for potential defects on the edges or cracks before any intervention. Never use damaged or worn products, as this could compromise the safety of the treatment. As the products are delivered non-sterile, strict compliance with reprocessing protocols is mandatory. Compatibility with other instruments must also be verified beforehand to avoid any undesirable electrochemical or mechanical interaction during sterilization.
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 (Class Ir according to the MDC0483 marking mentioned in the technical data). The manufacturer complies with strict regulatory requirements for the production of manual instruments intended for dentistry. As a professional device, its placement on the market follows established safety protocols for reusable instruments. The quality of the steel used and the manufacturing process guarantee compliance with European standards for non-invasive medical devices.
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Specifications
| Manufacturer | Helmut Zepf |
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