Composite spatula for dental surgery
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: 24.751.332TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf composite spatula?
The Helmut Zepf composite spatula, bearing technical reference 24.751.332TI, is a manual instrument specifically developed for restorative dentistry procedures. Manufactured by Helmut Zepf Medizintechnik GmbH, it belongs to the Class I consumables category. This instrument is designed in medical stainless steel, a standard material for surgical instrumentation, ensuring compatibility with office cleaning and sterilization protocols. Its structure is optimized for the manipulation of composite materials, allowing the practitioner to work volumes and surfaces with a precise tactile response during the shaping of direct restorations.
What are the clinical indications for this instrument?
This manual instrument is indicated for use during dental care involving the placement of restorative materials. More specifically, it is used for the application and modeling of restorative composites. In clinical practice, the spatula allows for picking up the material, inserting it into the prepared cavity, and sculpting the dental anatomy before hardening. It is involved in the stratification and smoothing stages of surfaces to ensure optimal marginal adaptation. Its use is strictly reserved for qualified healthcare professionals working in dental and restorative surgery.
What are the technical characteristics of the 24.751.332TI spatula?
The Helmut Zepf spatula (24.751.332TI) is characterized by its construction from high-quality medical stainless steel. As a Class I device, it meets the durability and resistance requirements necessary for manual instrumentation. The product is delivered non-sterile by the manufacturer Helmut Zepf Medizintechnik GmbH, which implies a complete preparation cycle before its first use. Its ergonomic design is intended to facilitate the technical gesture without compromising modeling precision. Compatibility with other products and instruments in the technical tray must be verified by the practitioner before any intervention.
What are the contraindications for the use of this instrument?
The main medical contraindication identified concerns patients with a known intolerance or sensitivity to metals, particularly the medical stainless steel used for the manufacture of this instrument. Contact with the spatula could trigger a hypersensitivity reaction in these subjects. If such a reaction occurs during the clinical act, the manufacturer specifies that the procedure must be stopped immediately and necessary medical measures must be taken. It is therefore crucial to evaluate the patient's allergic history before using any manual metallic instrument.
What are the maintenance and sterilization precautions?
All Helmut Zepf instruments must imperatively be cleaned, disinfected, and sterilized before their first use and after each subsequent use. The reprocessing process must be complete to ensure patient safety. Before each use, the practitioner must visually inspect the instrument to detect any damage or signs of wear, such as cracks, breaks, or defects on the active parts. It is formally forbidden to use a damaged product. Due to the robust design and materials used by Helmut Zepf Medizintechnik GmbH, there is no defined maximum limit of processing cycles, as long as the physical integrity of the instrument is preserved.
Who is the manufacturer and what standards are respected?
The instrument is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Seitingen-Oberflacht, Germany. This medical device is classified as Class I (Class Ir according to certain reprocessing nomenclatures) in accordance with current regulations. The manufacturer ensures the compliance of its products with medical stainless steel standards. As a Class I device, it follows the conformity assessment procedures required for manual dental instruments. Compliance with the cleaning and sterilization protocols described by Helmut Zepf is essential to maintain the device's compliance throughout its useful life in a clinical environment.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
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