Bionik Composite Spatula/Condenser - Helmut Zepf (26.120.21TI) - Delynov
The Spatule/Fouloir Composite Bionik - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 26.120.21TI.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Bionik Helmut Zepf composite spatula/plugger?
The Bionik composite spatula/plugger, referenced under code 26.120.21TI, is a manual instrument designed by the manufacturer Helmut Zepf Medizintechnik GmbH. This double-ended device is specifically developed for the manipulation of aesthetic restorative materials. Its structure combines a spatula-type active part for the delivery and modeling of the material, and a dental composite plugger part for condensation. Although the name mentions titanium, the manufacturer specifies that the instrument is designed in high-quality medical stainless steel, ensuring the necessary rigidity for compaction maneuvers while maintaining a fineness suitable for modeling cavity walls.
What are the clinical indications for this instrument?
This instrument is indicated for all restorative dentistry procedures using composite materials or cements. In conservative surgery, it is used for the layer-by-layer application of resins, allowing for precise anatomical modeling of occlusal and proximal surfaces. The use of the titanium composite plugger is particularly relevant when filling Class I to V cavities, where material condensation is critical to avoid interfacial voids. It can also be used during bonding procedures for indirect restorations or for the application of cavity liners, offering essential versatility during direct restorations in the anterior or posterior sector.
What are the technical characteristics of reference 26.120.21TI?
Reference 26.120.21TI from Helmut Zepf is distinguished by its double configuration, integrating a fine spatula and a plugger. As a manual instrument, it does not include a needle. Its design is based on the use of medical stainless steel, chosen for its mechanical resistance and durability throughout reprocessing cycles. The instrument is delivered non-sterile, in accordance with standards for reusable devices. Its geometry is optimized to access difficult-to-reach areas, while allowing the practitioner to exert controlled pressure during composite condensation, thus guaranteeing perfect adaptation of the material to the prepared tooth walls.
What are the contraindications for the use of this device?
The main medical 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 procedure, the manufacturer stipulates that the procedure must be immediately stopped and necessary medical measures must be taken. It is the practitioner's responsibility to check the patient's allergic history before any use of this manual instrument in the mouth.
What are the precautions for use and reprocessing?
As it is a non-absorbable and reusable instrument, strict maintenance protocols apply. All Helmut Zepf instruments must be cleaned, disinfected, and sterilized before the first use and after each subsequent use. It is imperative to inspect the instrument for visible damage such as cracks, breaks, or defects on the edges before each intervention. The use of damaged or worn products is prohibited. Due to its robust steel design, there is no defined maximum limit for treatment cycles, but compatibility with other cleaning and sterilization products must be verified beforehand by the healthcare professional.
Who is the manufacturer and what standards are respected?
The device is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized company located in Germany. This product belongs to Class I according to the regulatory classification of medical devices. The manufacturer ensures the traceability and compliance of its instruments with the safety requirements in force for manual devices. In accordance with regulations, the use of this instrument is strictly reserved for qualified healthcare professionals. Compliance with the cleaning and sterilization instructions issued by Helmut Zepf is essential to ensure patient safety and the longevity of the instrumentation within the dental practice.
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Specifications
| Manufacturer | Helmut Zepf |
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