Applicator for augmentation material - Helmut Zepf (19.714.16) - Delynov
The Applicateur de matériel d'augmentation - Helmut Zepf is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 19.714.16.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Helmut Zepf augmentation material applicator (19.714.16)?
The Helmut Zepf augmentation material applicator, referenced under code 19.714.16, is a manual dental instrument designed for the manipulation of biomaterials in oral surgery. Manufactured in medical stainless steel by Helmut Zepf Medizintechnik GmbH, this robust device is specifically structured to serve as a graft carrier. It allows the practitioner to harvest, transport, and precisely deposit bone substitutes or filling materials within surgical sites, thus ensuring a controlled application of the augmentation material during bone reconstruction protocols.
What are the clinical indications for this biomaterial applicator?
This instrument is indicated for all implant and periodontal surgery interventions requiring the addition of exogenous or autologous materials. As a bone applicator, it is used during sinus lift procedures, guided bone regeneration (GBR), or post-extraction socket filling. Its design facilitates access to narrow areas and allows for a homogeneous placement of the bone graft carrier. It is intended exclusively for use by qualified healthcare professionals within the framework of specific dental and surgical care.
What are the technical characteristics of instrument 19.714.16?
The Helmut Zepf applicator (19.714.16) is a Class I instrument manufactured from high-quality medical stainless steel. This material is chosen for its resistance to repeated sterilization cycles and its standard biocompatibility. The instrument is delivered non-sterile and must imperatively undergo a full cycle of cleaning, disinfection, and sterilization before its first use, as well as after each subsequent use. Due to its design and the materials used, the manufacturer does not establish a defined maximum limit for the number of processing cycles, as long as the integrity of the instrument is preserved.
What are the contraindications for the use of this instrument?
The main medical contraindication related to the use of this applicator is known patient hypersensitivity or intolerance to metals, particularly to the components of medical stainless steel. Contact with the instrument may trigger a hypersensitivity reaction in sensitive subjects. If such a reaction occurs during the intervention, the procedure must be immediately interrupted and necessary medical measures must be taken. Furthermore, the use of the instrument is strictly prohibited if visible damage, such as cracks, breaks, or defects on the edges, is observed during preoperative inspection.
What are the maintenance and reprocessing precautions?
To ensure the safety of care, all Helmut Zepf instruments must be cleaned, disinfected, and sterilized before each use. It is crucial to check the condition of the biomaterial applicator before use: any sign of wear or damage (cracks, surface defects) must lead to its immediate disposal. Never use damaged products. Reprocessing must follow standard hospital or dental office sterilization protocols. As it is a non-resorbable steel instrument, compatibility with other products used during the intervention must also be verified beforehand by the practitioner.
Who is the manufacturer and what standards are respected?
The applicator is manufactured by Helmut Zepf Medizintechnik GmbH, a recognized manufacturer located in Seitingen-Oberflacht, Germany. This medical device belongs to Class I according to current regulations. The manufacturer imposes strict safety and usage instructions, reminding that the instrument is reserved for healthcare professionals. Each product is subject to rigorous quality controls to meet the requirements for manual dental instruments. Traceability is ensured by the technical reference 19.714.16, guaranteeing the origin and compliance of the material provided by Delynov.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Helmut Zepf |
| Tags | |
|---|---|
| Tags | |