Luxator Handle Number 510 5mm Curved - Hu-Friedy - Delynov
The Luxateur 5mm courbé, 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.
What is the Hu-Friedy 5mm curved luxator?
The 5mm curved luxator, #510 handle, is a manual instrument developed by the manufacturer Hu-Friedy Mfg. Co., LLC for oral surgery. This device is distinguished by its 5mm wide working part featuring a specific curvature to match root anatomy. Its structure is optimized to insert into the periodontal space. Unlike a standard elevator, its design is focused on sectioning ligament fibers. This instrument is a Class I device, manufactured by Hu-Friedy, a recognized player in the field of surgical instrumentation, ensuring compliance with regulatory requirements for non-invasive or invasive devices for temporary use.
What are the clinical indications for this instrument?
This Hu-Friedy device is indicated for the luxation of teeth during exodontia procedures. In oral and implant surgery, it is used to initiate tooth mobility by sectioning ligament attachments around the entire circumference of the root. The 5mm width is particularly suitable for wide sites or molars. The use of this luxator allows for socket preparation before extraction, which is crucial in immediate implant placement protocols where the integrity of the alveolar bone walls must be preserved. It is exclusively reserved for use by qualified healthcare professionals in clinical or hospital settings.
What are the technical characteristics of the #510 handle?
The luxator features the #510 handle from Hu-Friedy, a specific technical reference in the manufacturer's catalog. This handle is designed to provide a stable grip during axial and circular luxation maneuvers. The 5mm active part is curved, which facilitates access to posterior zones or root surfaces that are difficult to reach with a straight instrument. The junction between the shank and the handle is designed to effectively transmit the force necessary for penetration into the periodontal space without compromising surgical control. The manufacturing quality of Hu-Friedy Mfg. Co., LLC ensures the instrument's durability through repeated sterilization cycles.
What are the contraindications for the use of this luxator?
According to information from the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is strictly reserved for healthcare professionals. Although the raw MDR text does not list specific medical contraindications related to systemic pathologies or material allergies, the use of this luxator is contraindicated for applications other than those intended in dental surgery. It must not be used as a high-force lever (elevator), as this risks fracturing the thin 5mm blade or damaging the bone plates. Practitioners should refer to the instructions for use to identify any additional restrictions related to the patient's clinical status.
What are the maintenance and use precautions?
As a Class I device, this Hu-Friedy luxator must be treated according to the standard decontamination and sterilization protocols in effect in dental practices. Before each use, it is imperative to carefully read the instructions provided by Hu-Friedy Mfg. Co., LLC. The instrument must be inspected to verify the absence of corrosion or deformation of the 5mm curved blade. Particular attention should be paid to cleaning the junction areas of the #510 handle to remove any organic residue. Being a non-resorbable and reusable instrument, its longevity depends on strict compliance with the manufacturer's warnings regarding thermal and chemical cleaning.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This luxator is classified as a Class I medical device. Hu-Friedy's compliance with manufacturing standards ensures that the instrument meets safety and performance requirements for oral surgery procedures. The manufacturer emphasizes that this product is reserved exclusively for healthcare professionals. For any additional information on compliance or technical specifications, it is recommended to consult the official technical documentation and the instructions for use accompanying the Hu-Friedy product upon delivery by Delynov.
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Specifications
| Manufacturer | Hu-Friedy |
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