Elevator number 81A with handle number 510 - Hu-Friedy - Delynov
The Elévateur #81A manche #510 - Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.
- Compliance: Medical device Class I.
- Manufacturer: Hu-Friedy Mfg. Co., LLC.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Hu-Friedy |
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What is the Hu-Friedy #81A elevator with #510 handle?
L'élévateur #81A, associé au manche #510, est un instrument manuel de haute qualité. Ce dispositif est spécifiquement conçu pour les interventions de chirurgie orale et les extractions. Sa structure se compose d'une partie active, modèle #81A, montée sur un manche ergonomique de type #510. Cet équipement répond aux exigences des praticiens recherchant un instrument fiable pour la luxation. En tant que produit de la marque Hu-Friedy, il bénéficie de l'expertise d'un fabricant reconnu dans le domaine de l'instrumentation chirurgicale, garantissant une intégration optimale dans le protocole clinique quotidien des cabinets de chirurgie orale et des centres d'implantologie.
What are the clinical indications for this instrument?
This elevator is indicated for the luxation of teeth and roots prior to forceps extraction. In oral surgery, its role is essential for separating the tooth from its ligamentous attachments and for widening the socket. It is particularly useful in cases of complex extractions, fractured roots, or impacted teeth where direct access is limited. Use of this Hu-Friedy instrument allows for the preparation of the site for potential implant placement while best preserving the integrity of the alveolar bone walls. Its application is strictly reserved for qualified healthcare professionals mastering exodontia and periodontal surgery techniques.
What are the technical characteristics of the #81A elevator?
The #81A elevator is distinguished by the specific geometry of its active tip, optimized to effectively insert into the periodontal space. The #510 handle offers a grip adapted to the force and precision constraints encountered during elevation maneuvers. This device belongs to Class I according to the regulatory classification of medical devices. Manufacturing by Hu-Friedy Mfg. Co., LLC ensures compliance with rigorous production standards. Although material specifications are not detailed in the source data, the design is oriented towards resistance to sterilization cycles and the durability necessary for repeated use in a surgical environment.
What are the contraindications for the use of this device?
Contraindications for the use of the #81A elevator with #510 handle are related to clinical dental extraction protocols. It should not be used if the surrounding bone structures are too fragile to support leverage forces, or in case of immediate proximity to sensitive anatomical structures (nerves, sinuses) without prior planning. Although the raw MDR text mentions the existence of indications and contraindications provided by the manufacturer Hu-Friedy, no specific material allergies are listed in the source documentation. It is the practitioner's responsibility to evaluate the benefit/risk ratio based on the patient's general health status and the complexity of the planned surgical procedure.
What are the maintenance and safety precautions?
As a Class I instrument, this elevator must be handled with care to maintain its performance. Before any use, it is imperative to carefully read the instructions provided by Hu-Friedy. The instrument is reserved exclusively for healthcare professionals. The cleaning, disinfection, and sterilization process must strictly follow the manufacturer's recommendations to ensure asepsis and prevent cross-contamination. A visual inspection of the #81A tip and the #510 handle is recommended before each intervention to detect any signs of wear or degradation that could compromise patient safety or the effectiveness of the surgical movement during luxation.
Who is the manufacturer and what standards are respected?
L'instrument est fabriqué par Hu-Friedy Mfg. Co., LLC, dont le siège est au 3232 N. Rockwell St. Chicago, Il 60618 USA. Ce dispositif médical est de Classe I, ce qui correspond aux normes réglementaires pour les instruments chirurgicaux réutilisables non invasifs ou invasifs à usage temporaire. Hu-Friedy est un fabricant mondialement reconnu pour la qualité de son instrumentation. La conformité aux protocoles de fabrication et le respect des exigences de la Classe I offrent aux praticiens de chirurgie orale un outil répondant aux normes actuelles de sécurité et de performance. Il est essentiel de se référer à l'étiquetage et à la notice d'utilisation pour toute information complémentaire concernant des certifications spécifiques non détaillées ici.
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