Papilla Detacher/Elevator - Helmut Zepf (46.035.05)
The Décolleur/Élévateur de Papille - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 46.035.05.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf papilla elevator?
The Helmut Zepf papilla elevator, referenced under code 46.035.05, is a specialized manual instrument for oral surgery. Manufactured from high-quality medical stainless steel by Helmut Zepf Medizintechnik GmbH, this instrument is designed to offer optimal resistance during tissue manipulation. It belongs to Class I of medical devices. Its structure is specifically adapted to fit into narrow interproximal spaces, allowing the practitioner to perform a controlled elevation of the papilla without unnecessary damage to adjacent structures.
What are the clinical indications for this papilla elevator?
This papilla elevator is indicated for all interventions requiring precise management of periodontal soft tissues. In implant surgery or periodontology, it is used to lift full-thickness or partial-thickness flaps, particularly at the level of the interdental papillae. Its use is essential during the placement of membranes, bone grafts, or simply to clear the operative field during open flap root planing. It allows for a clean separation between the periosteum and the alveolar bone.
What are the technical characteristics of the dental papilla elevator?
The Helmut Zepf dental papilla elevator (46.035.05) is distinguished by its medical stainless steel design, guaranteeing standard biological compatibility for surgical instruments. As a Class I device, it meets the safety requirements for non-invasive or invasive instruments for temporary use. The manufacturer Helmut Zepf Medizintechnik GmbH delivers this product non-sterile, requiring a complete processing protocol before each use. Its geometry is specifically designed to meet the constraints of modern dental micro-surgery.
What are the contraindications for the use of this instrument?
The main contraindication mentioned by the manufacturer Helmut Zepf concerns the patient's known hypersensitivity to metals. As the instrument is composed of medical stainless steel, an allergic reaction or intolerance may occur upon contact with the tissues. If a hypersensitivity reaction is triggered during the intervention, the procedure must be immediately stopped and the necessary clinical measures must be taken. It is therefore recommended to check the patient's allergic history before any use.
What are the maintenance and sterilization precautions?
Like any reusable surgical instrument, this papilla elevator must imperatively be cleaned, disinfected, and sterilized before the first use, and then after each subsequent use. The manufacturer emphasizes the importance of checking the condition of the instrument before each intervention: the presence of visible damage, cracks, breaks, or defects on the cutting edges makes the instrument unfit for use. Although there is no defined maximum limit for processing cycles, natural wear and the materials used determine the end of the product's life.
Who is the manufacturer and what standards are respected?
This instrument is manufactured by Helmut Zepf Medizintechnik GmbH, located in Seitingen-Oberflacht, Germany, a recognized manufacturer in the dental instrumentation sector. The elevator complies with the regulations for Class I medical devices. Compliance with cleaning and sterilization protocols is the responsibility of the healthcare professional, as the instrument is delivered non-sterile. The use of this device is strictly reserved for healthcare professionals qualified in dental and oral surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Helmut Zepf |
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