Composite Spatula with Bionik Handle - Helmut Zepf (26.120.11TI) - Delynov
The Spatule Composite avec Manche Bionik - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.120.11TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf 26.120.11TI composite spatula?
The Helmut Zepf composite spatula, referenced under code 26.120.11TI, is a precision manual instrument designed for the handling of restorative materials. It is distinguished by its ergonomic Bionik handle, developed to offer optimal grip during delicate modeling phases. Manufactured by Helmut Zepf Medizintechnik GmbH, this spatula is designed in medical stainless steel, guaranteeing the rigidity necessary for composite application while maintaining a structure adapted to the clinical requirements of modern dental surgery.
What are the clinical indications for this instrument?
This instrument is indicated for all restorative dentistry procedures requiring the application and shaping of composite materials. Its primary use concerns the filling of cavities, where it allows for transporting the material and sculpting it according to natural dental anatomy. In conservative surgery, this composite spatula aids in adjusting resin layers, ensuring precise adaptation to cavity walls. It is perfectly suited for practitioners seeking a reliable tool for anterior and posterior restorations.
What are the technical characteristics of the spatula?
The Helmut Zepf 26.120.11TI spatula is characterized by the integration of the Bionik handle, a series recognized for its advanced ergonomics that reduces manual fatigue during prolonged use. The working part is optimized to avoid excessive adhesion of composite materials, thus facilitating homogeneous smoothing. As a Class I device, this instrument meets the rigorous manufacturing standards of Helmut Zepf Medizintechnik GmbH. It is delivered non-sterile and must undergo a full cleaning and sterilization cycle before its first use in the practice.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf 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 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 recommended to check the patient's allergic history before any manipulation with this steel instrument.
What are the maintenance and reprocessing precautions?
Like any reusable Helmut Zepf instrument, this spatula must be cleaned, disinfected, and sterilized before each use. The manufacturer specifies that no maximum treatment cycle can be defined due to the robust design of the instrument, but a visual inspection is mandatory. Before use, the practitioner must check for the absence of visible damage such as cracks, breaks, or defects on the active parts. Any product showing signs of wear or structural damage must never be used in order to guarantee patient safety and the effectiveness of the clinical procedure.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is the company Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations (Class Ir - MDC0483). Manufacturing complies with the high quality standards imposed for manual dental instruments in stainless steel. As a Helmut Zepf product, it benefits from complete technical traceability, although it is delivered non-sterile, leaving the responsibility for final reprocessing to the qualified healthcare professional.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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