Buser Periosteal Elevator #10 handle - Hu-Friedy - Delynov
The Décolleur Buser manche #10 - 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.
What is the Buser elevator #10 handle - Hu-Friedy?
The Buser elevator #10 handle is a high-quality surgical instrument manufactured by Hu-Friedy Mfg. Co., LLC. This specific tool, belonging to the surgical instruments category (INSTRU), is designed for the manipulation of soft tissues and the periosteum. Its structure includes a working part optimized for mucoperiosteal elevation and an ergonomic #10 type handle. As a Class I medical device, it meets the rigorous manufacturing standards of Hu-Friedy, a recognized manufacturer in the dental sector. This instrument is essential for preparing the surgical field by exposing bone structures while preserving the integrity of epithelial-connective flaps during the initial phases of the intervention.
What are the clinical indications for this Hu-Friedy instrument?
The Buser elevator is primarily indicated in oral surgery, periodontology, and implantology. Its intended use concerns the atraumatic detachment of full-thickness flaps. It is used by healthcare professionals to separate the periosteum from the cortical bone, thus allowing clear exposure of the site for procedures such as the extraction of impacted teeth, guided bone regeneration (GBR), or the placement of implant fixations. The use of this Hu-Friedy instrument is strictly reserved for qualified healthcare professionals, ensuring application in accordance with current clinical protocols. It allows for precise management of soft tissues, which is essential for achieving tension-free wound closure postoperatively.
What are the technical characteristics of the Buser elevator?
Technically, this device is distinguished by its #10 handle, offering a grip adapted to the fine movements of microsurgery and conventional oral surgery. Manufactured by Hu-Friedy Mfg. Co., LLC, this instrument benefits from the industrial expertise of the Chicago-based manufacturer. Although the exact composition is not specified, Hu-Friedy instruments are renowned for their strength and finish. This elevator is classified as a Class I medical device, which implies specific regulatory monitoring for non-invasive or invasive instruments for temporary use. Its design allows for cleaning and sterilization in accordance with the requirements of a dental operating room, ensuring the safety and longevity of the tool.
What are the contraindications for the use of this device?
According to the information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, specific contraindications are not exhaustively listed beyond general usage warnings. However, the use of this instrument is formally reserved for trained healthcare professionals. An obvious clinical contraindication would be the use of the instrument on tissues presenting pathologies incompatible with flap surgery or in patients with general contraindications to oral surgery. It is imperative to read the instructions carefully before use to ensure the device is employed according to its intended use and to identify any restrictions related to the patient's health status or the planned surgical technique.
What are the precautions for use and maintenance for this elevator?
Like any Class I surgical instrument intended for oral surgery, the Hu-Friedy Buser elevator requires rigorous handling. It is not a resorbable product, but a reusable instrument that must undergo a complete cycle of decontamination, cleaning, and sterilization between each patient. Professionals must take care not to alter the working ends during cleaning to maintain the effectiveness of the periosteal elevation. The manufacturer Hu-Friedy emphasizes the importance of consulting the technical instructions to respect the recommended sterilization parameters. A visual inspection before each intervention is recommended to check for the absence of corrosion or deformation, thus ensuring patient safety and the precision of the surgical gesture.
Who is the manufacturer and what standards are met by this product?
The Buser elevator #10 handle is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, IL 60618, USA. This manufacturer is a world leader in the production of dental instrumentation. The product is listed under Class I according to medical device regulations. Although specific CE marking is not mentioned in the source data, compliance with Hu-Friedy manufacturing standards ensures conformity with professional quality requirements. The raw MDR text confirms that use is strictly reserved for healthcare professionals and insists on reading the instructions before any handling. This regulatory framework guarantees that the instrument has been designed to meet the specific needs of modern dental surgery.
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Specifications
| Manufacturer | Hu-Friedy |
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