Spatula for composite - Helmut Zepf (24.751.324TI) - 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: 24.751.324TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf composite spatula?
The Helmut Zepf composite spatula, referenced under code 24.751.324TI, is a specific manual instrument intended for restorative dentistry. Manufactured by Helmut Zepf Medizintechnik GmbH, this device belongs to the category of Class I consumables and instruments. Designed in medical stainless steel, this spatula features a structure adapted for handling composite materials. It is delivered non-sterile by the manufacturer and requires a complete cleaning, disinfection, and sterilization protocol before its first use as well as between each patient to ensure optimal safety of use in the dental office.
What are the clinical indications?
The intended use for this Helmut Zepf manual instrument is strictly limited to dental procedures. It is indicated for the manipulation of restorative materials, particularly composites, during the cavity filling and modeling phases. In conservative surgery, it allows the practitioner to place and sculpt the material before its polymerization. Its use is reserved exclusively for qualified healthcare professionals. The manufacturer specifies that compatibility with other products used during the intervention must be systematically verified beforehand by the practitioner to ensure the success of the clinical procedure.
What are the technical characteristics of this instrument?
This Helmut Zepf spatula, bearing the technical reference 24.751.324TI, is designed from medical grade stainless steel. As a Class I device, it meets the design requirements for non-invasive or short-term invasive manual instruments. The product is delivered in a non-sterile state, implying mandatory reprocessing before use. Due to its robust design and selected materials, the manufacturer indicates that there is no defined maximum limit for achievable processing cycles, although the instrument must be visually inspected for any signs of wear, cracks, or defects on the active parts before each intervention.
What are the contraindications for use?
The main contraindication documented by Helmut Zepf Medizintechnik GmbH concerns hypersensitivity or intolerance to metals. Contact with this medical stainless steel instrument can trigger an allergic reaction in sensitive patients. If such a hypersensitivity reaction occurs during the procedure, the manufacturer stipulates that the intervention must be immediately interrupted and necessary medical measures must be taken. It is therefore essential to evaluate the patient's allergic history before any manipulation. Furthermore, the use of an instrument showing visible damage, such as breaks or defective cutting edges, is formally prohibited.
What are the maintenance and reprocessing precautions?
Reprocessing the Helmut Zepf composite spatula is a critical step. All instruments must imperatively be cleaned, disinfected, and sterilized before the first use and after each subsequent use. Cleaning must be complete to remove all residue before the sterilization cycle. The practitioner must perform a meticulous inspection to identify any visible damage, cracks, or abnormal wear. The use of a damaged product is dangerous and prohibited. Although the material allows for many treatment cycles without a predefined limit, the longevity of the instrument directly depends on compliance with the cleaning and sterilization protocols recommended by the manufacturer.
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 is classified as Class I according to current regulations. As a recognized manufacturer, Helmut Zepf ensures the traceability and quality of its manual instruments intended for healthcare professionals. Compliance with medical standards is ensured by the use of medical stainless steel and adherence to rigorous manufacturing processes. Users must refer to the manufacturer's instructions for cleaning and sterilization to maintain the instrument in compliance with the safety and clinical efficacy requirements expected for Class I devices.
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Specifications
| Manufacturer | Helmut Zepf |
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