MODIFIED PRICHARD PERIOSTEAL INSERT WITH NOTCH, INTERCHANGEABLE INSERT, BLACK COATING (41.751.61ROX) - Helmut ZEPF - Delynov
The INSERT PÉRIOSTÉAL PRICHARD MODIFIÉ AVEC ENCOCHE, INSERT INTERCHANGEABLE, REVÊTEMENT NOIR- Helmut ZEPF is a medical device manufactured by Helmut Zepf Medizintechnik GmbH.
- Compliance: Medical device Class I.
- Manufacturer: Helmut Zepf Medizintechnik GmbH.
- Reference: 41.751.61ROX.
- Reserved for healthcare professionals. Read instructions carefully before use.
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What is the Helmut Zepf modified Prichard periosteal insert?
The modified Prichard periosteal insert, referenced under code 41.751.61ROX by the manufacturer Helmut Zepf Medizintechnik GmbH, is a specialized surgical instrument intended for the manipulation of soft tissues. This device is distinguished by its nature as an interchangeable insert, allowing modularity with compatible handles from the range. It features a specific black coating (ROX) and a Prichard-type geometry including a notch. This periosteal elevator is a precision tool used to separate the periosteum from the bone surface in a controlled manner during surgical exposure phases.
What are the clinical indications for this Prichard elevator insert?
This Prichard elevator insert is primarily indicated in oral surgery, periodontology, and implantology. Its use is reserved for healthcare professionals for procedures requiring precise elevation of the full-thickness flap. The specific notch of the modified model facilitates the maintenance and retraction of periosteal tissues, providing optimal visibility of the surgical site. It is used during the preparation of implant sites, the treatment of bone defects, or any intervention requiring rigorous mucoperiosteal reflection to access the alveolar bone.
What are the technical characteristics of the 41.751.61ROX insert?
The Helmut Zepf periosteal insert is characterized by its interchangeable design, offering instrumental flexibility to the practitioner. Reference 41.751.61ROX incorporates a black coating, often associated with a reduction in reflections under operating lights and better surface resistance. The modified Prichard shape with a notch allows for anatomical adaptation during tissue lifting. As a Class I device, this instrument meets standard regulatory requirements for non-invasive or transiently invasive surgical instruments.
What are the contraindications for the use of this device?
According to information from the manufacturer Helmut Zepf Medizintechnik GmbH and associated regulatory data, the use of this insert is strictly reserved for qualified healthcare professionals. General contraindications include any clinical situation where the condition of the soft tissues or bone does not allow for safe flap elevation. Although specific materials are not detailed in the technical sheet, standard precautions regarding allergies to metallic components of surgical instruments must be observed by the practitioner before any intervention.
What are the precautions for use for this non-resorbable insert?
As this is a metallic surgical instrument and not a suture material, the question of resorption does not apply. However, strict maintenance precautions are necessary. As an interchangeable insert, it must be correctly fixed to its handle before use to guarantee the safety of the procedure. The practitioner must follow current cleaning, disinfection, and sterilization protocols for reusable Class I medical devices. It is imperative to carefully read the instructions for use provided by the manufacturer before any handling to ensure the longevity of the black coating.
Who is the manufacturer and what standards are met?
The official manufacturer of this periosteal insert is Helmut Zepf Medizintechnik GmbH. The product is classified as a Class I medical device in accordance with current regulations. Warnings and intended use are also documented in relation to the manufacturing standards of Hu-Friedy (Chicago, USA) mentioned in the traceability data. This device is exclusively reserved for professional use in a surgical environment. Compliance with sterilization protocols and Helmut Zepf manufacturer indications is essential to guarantee compliance and safety during clinical interventions.
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