Composite Spatula Fig. 2 - Helmut Zepf (24.751.319TI) - Delynov
The SPATULE POUR COMPOSITE. FIG. 2 - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 24.751.319TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf composite spatula?
The Helmut Zepf composite spatula, referenced under code 24.751.319TI, is a manual instrument specifically designed for dental restoration work. Manufactured by Helmut Zepf Medizintechnik GmbH, this composite filling spatula is structured to offer optimal handling of filling materials. It belongs to the category of Class I consumables and instruments. Its medical stainless steel design meets the durability and resistance requirements necessary in a dental practice. As a manual instrument, it serves as an interface between the practitioner and the composite material to ensure precise placement in prepared cavities.
What are the clinical indications?
This instrument is indicated for all restorative dentistry procedures requiring the use of composites. It is primarily used to pick up, deposit, and model composite resins, cements, or other filling materials. In conservative surgery, the composite spatula fig 2 allows for sculpting the dental anatomy before light-curing. It is suitable for marginal adaptation of materials and surface smoothing. Its use is strictly reserved for qualified healthcare professionals, ensuring application in accordance with current clinical protocols for aesthetic and functional restorations.
What are the technical characteristics?
The Helmut Zepf spatula (ref: 24.751.319TI) is distinguished by its Fig. 2 configuration, adapted to the specific needs of intraoral modeling. It is made of medical stainless steel, a material chosen for its biocompatibility and resistance to sterilization cycles. The instrument is delivered non-sterile and must undergo a cleaning, disinfection, and sterilization protocol before its first use and after each subsequent use. Its design allows for ergonomic handling for the practitioner, facilitating precision of movement during composite insertion. No maximum use cycle is defined, as the lifespan depends on maintenance and the absence of visible damage.
What are the contraindications for use?
The main medical contraindication mentioned by the manufacturer Helmut Zepf Medizintechnik GmbH concerns known hypersensitivity or intolerance to metals. As the instrument is composed 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. Furthermore, it is strictly forbidden to use the instrument if it shows visible damage such as cracks, breaks, or defects on the edges, as this could compromise patient safety and treatment efficacy.
What are the maintenance and reprocessing precautions?
As a non-resorbable and reusable instrument, a strict reprocessing protocol is required. Before each use, the practitioner must inspect the instrument for any signs of wear or corrosion. Cleaning must be complete before sterilization. As it is a Class I device, compliance with the manufacturer's safety instructions is crucial to maintain the integrity of the steel. Products must be cleaned, disinfected, and sterilized in accordance with hospital standards. Due to the quality of the materials used by Helmut Zepf, there is no predefined limit for treatment cycles, as long as the instrument does not show physical alteration detrimental to its function or hygiene.
Who is the manufacturer and what standards are met?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This product is classified as a Class I medical device according to current regulations (MDR). Although specific CE marking is not detailed in the source data, the instrument meets the manufacturing standards for manual stainless steel medical devices. Compliance with cleaning and sterilization requirements is essential for its professional use. Helmut Zepf guarantees a high-quality instrument intended exclusively for dental health experts, respecting safety protocols related to reusable invasive instruments.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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