Osteotomy Bone-Pusher Number 3.32 Straight 3.2mm Cylindrical - Hu-Friedy - Delynov
The Ostéotom Bone-Pusher #3.32 droit 3.2mm cylindrique - 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 Bone-Pusher #3.32 straight 3.2mm cylindrical osteotome - Hu-Friedy?
L'ostéotome Bone-Pusher #3.32 est un instrument manuel spécialisé conçu par Hu-Friedy pour les procédures de chirurgie orale et d'implantologie. Cet instrument se caractérise par une extrémité de travail cylindrique d'un diamètre de 3,2 mm et une tige droite. Il est principalement utilisé comme ostéotome pour manipuler, compacter ou déplacer le tissu osseux et les matériaux de greffe. Fabriqué par Hu-Friedy Mfg. Co., LLC, cet instrument répond aux exigences de qualité d'un fabricant reconnu dans le secteur de la chirurgie orale. Sa conception robuste permet une transmission efficace de la force lors des manœuvres de condensation osseuse nécessaires à la préparation du site receveur.
What are the clinical indications for this osteotome?
This instrument is indicated for bone surgery procedures where bone densification or displacement is required. In implantology, the Hu-Friedy Bone-Pusher osteotome is used to compact cancellous bone to improve primary implant stability. It is also employed during crestal approach sinus lift techniques to gently push bone filling material under the sinus membrane. Its 3.2mm cylindrical shape is particularly suited to drilling sites of corresponding diameter, allowing for precise fit and optimal control of the bone volume displaced during the implant preparation phase.
What are the technical characteristics of the instrument?
L'ostéotome Bone-Pusher #3.32 présente des spécifications techniques précises pour répondre aux besoins des praticiens. Il est doté d'une partie active cylindrique de 3,2 mm de diamètre, idéale pour les protocoles chirurgicaux standardisés. Sa configuration droite permet une application de force axiale, essentielle pour la compaction verticale. Cet instrument bénéficie d'une finition rigoureuse assurant une manipulation fiable. Il appartient à la catégorie des consommables réutilisables (CONSO) et est classé comme dispositif médical de Classe I selon la réglementation en vigueur, garantissant sa conformité pour un usage professionnel en chirurgie orale ou en milieu hospitalier.
What are the contraindications for the use of this device?
According to information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is strictly reserved for qualified healthcare professionals. General clinical contraindications apply, particularly when the patient's health status or local bone quality does not allow for invasive surgical intervention. Although the raw MDR text does not list specific material-related contraindications, the practitioner must ensure the patient does not have hypersensitivity to common metallic components of surgical instruments. It is imperative to read the instructions for use carefully and follow sterilization protocols before any intervention to avoid cross-infection risks.
What are the precautions for use and maintenance?
Like any Class I bone surgery instrument, the Hu-Friedy osteotome requires rigorous maintenance. Before the first use and after each intervention, the device must be cleaned, disinfected, and sterilized in accordance with the manufacturer's instructions. The practitioner must inspect the 3.2mm cylindrical tip to check for any deformation or damage that could compromise the precision of the surgical gesture. During use, excessive force must be avoided to prevent any risk of unwanted bone fracture or damage to the instrument. Handling must remain precise and compliant with osteotomy techniques taught in oral and implant surgery.
Who is the manufacturer and what standards are met?
The instrument is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. Hu-Friedy is a globally recognized manufacturer for the quality of its surgical instrumentation. This product is listed as a Class I medical device. Compliance with this regulatory class indicates that the instrument meets the safety and performance requirements defined for non-invasive or transient-use invasive medical devices. Healthcare professionals should refer to the manufacturer's warnings and consult the instructions for use to ensure use in compliance with current safety standards within their clinical practice.
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