Universal Bone Rasp Tabanella - Hu-Friedy - Delynov (product)
The Râpe à os universelle Tabanella - 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 Tabanella universal bone rasp - Hu-Friedy?
The Tabanella universal bone rasp, manufactured by Hu-Friedy, is a specific manual instrument intended for osteoplasty. It is presented as a robust tool designed for working on hard tissues in the oral cavity. This Hu-Friedy brand device is used to refine bone surfaces after using rotary instruments or rongeurs. Its design allows for precise handling for dental surgeons and implantologists. As a Class I product, it meets the basic regulatory requirements for non-invasive or transiently invasive surgical instruments. Its structure is optimized to offer an adequate tactile response during bone material removal.
What are the clinical indications for this instrument?
The clinical indications for the tabanella rasp primarily concern oral bone surgery. It is used for smoothing irregular alveolar ridges after multiple or single tooth extractions. In pre-implant surgery, this instrument allows for the regularization of the ridge in order to optimize the seating of soft tissues and prepare the implant site. It is also indicated for the removal of exostoses or residual bone spicules that could cause irritation under a prosthesis or hinder healing. Its use is strictly reserved for qualified healthcare professionals, in accordance with the directives of the manufacturer Hu-Friedy Mfg. Co., LLC.
What are the technical characteristics of the bone rasp?
The Tabanella universal bone rasp is characterized by a serrated working part allowing for controlled abrasion of the bone. Unlike sutures, this instrument does not have a needle but a monobloc or assembled architecture according to Hu-Friedy standards. Its universal morphology allows access to different sectors of the jaw, both in the maxilla and the mandible. Hu-Friedy manufacturing quality guarantees the resistance necessary for mechanical stresses encountered during bone rasping. As a Class I device, its technical specifications comply with the needs of daily practice in oral surgery offices for manual bone remodeling.
What are the contraindications for the use of this device?
According to the information provided by the manufacturer Hu-Friedy, specific contraindications are not listed exhaustively outside of the use reserved for healthcare professionals. However, from a standard clinical point of view, the use of the tabanella rasp is contraindicated in situations where the structural integrity of the bone does not allow for manual abrasion without risk of fracture, or in the presence of uncontrolled acute infections at the surgical site. It is imperative to carefully read the instructions for use provided by Hu-Friedy Mfg. Co., LLC before any intervention. The practitioner must evaluate the benefit/risk ratio based on the patient's general health status and underlying bone pathologies.
What are the precautions for use and maintenance?
As the universal bone rasp is a non-absorbable and reusable instrument, it requires a strict sterilization protocol between each patient. Although composition details are not specified, this type of Hu-Friedy instrument must be cleaned, disinfected, and sterilized according to the instructions of the manufacturer based in Chicago. Precautions include regular inspection of the rasp's serrations to ensure they are not dull, which would reduce the efficiency of the bone surgery and could cause overheating through excessive friction. It is reminded that this instrument is reserved exclusively for healthcare professionals and that the manual must be consulted for appropriate reprocessing cycles.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. The Tabanella universal bone rasp is classified as a Class I medical device. This classification indicates that the instrument meets the safety and performance standards applicable to this category of surgical devices. Hu-Friedy is a recognized manufacturer in the global dental sector for the quality of its manual instruments. Compliance with the use and maintenance protocols described by Hu-Friedy is essential to guarantee the longevity of the tool and the safety of the care provided to patients during bone surgery interventions.
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Specifications
| Manufacturer | Hu-Friedy |
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