Luxelevator 4mm Curved Black Series - Hu-Friedy - Delynov
The Luxateur 4mm courbé, Black Line - 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.
fabricant : Hu-friedy 3232 N. Rockwell St. Chicago, Il 60618 USA . Réservé aux professionnels de santé. Lire attentivement la notice avant utilisation.
What is the Hu-Friedy Black Line 4mm curved luxating elevator?
The 4mm curved luxating elevator, part of the Black Line range from the Hu-Friedy brand, is a precision surgical instrument designed to facilitate tooth extraction. This device is distinguished by its ergonomic design and its specific Black Line finish, optimizing visibility during oral surgery procedures. Manufactured by Hu-Friedy Mfg. Co., LLC, this tool is specifically developed to meet the requirements of practitioners seeking consistent performance. As a Class I device, it integrates perfectly into the therapeutic arsenal of dental practices and specialized implantology clinics, offering a robust solution for the delicate manipulation of hard tissues and root luxation.
What are the clinical indications for this instrument?
The use of the Hu-Friedy 4mm curved luxating elevator is indicated for simple or complex tooth extraction procedures. Its specific curvature and 4mm width allow access to the ligament spaces in order to separate the tooth from its socket with controlled force. This device is particularly useful in oral surgery and implantology to preserve the integrity of the alveolar bone before implant placement. The use of this instrument is strictly reserved for qualified healthcare professionals, such as dental surgeons and implantologists, thus ensuring application in accordance with current clinical protocols.
What are the major technical characteristics of this luxating elevator?
The Hu-Friedy 4mm curved luxating elevator is characterized by a 4mm wide tip, optimized for insertion into the periodontal space. The curved configuration of the blade allows for effective leverage in difficult-to-access areas, facilitating root luxation. This model is part of the Black Line series, recognized for its glare-reduction properties under operating lights, thereby improving the surgeon's visual comfort. The rigorous design by Hu-Friedy Mfg. Co., LLC ensures durability and resistance adapted to the mechanical stresses encountered during daily surgical procedures in dental practices.
What are the contraindications for the use of this device?
In accordance with information from the manufacturer Hu-Friedy, the use of this luxating elevator is contraindicated for any person who does not possess the required healthcare professional qualifications. It must not be used outside of its intended use, namely dental luxation and oral surgery. The practitioner must evaluate the specific risks for each patient before the procedure. It is imperative to read the instructions for use carefully before any handling. Inappropriate use or the application of excessive force can lead to damage to adjacent anatomical structures or instrument breakage, compromising patient safety.
What are the precautions for use and maintenance?
To guarantee the longevity of the Hu-Friedy Black Line 4mm curved luxating elevator, it is essential to follow the recommended cleaning and sterilization protocols for Class I instruments. Before each use, the professional must inspect the instrument to ensure the absence of structural defects or premature wear. As a non-resorbable device intended for mechanical manipulation, it requires rigorous maintenance. The manufacturer's warnings from Hu-Friedy specify that the instrument is reserved exclusively for healthcare professionals. Compliance with sterilization cycles and appropriate storage are crucial to maintain the cutting and leverage performance of the 4mm blade.
Who is the manufacturer and what regulatory standards are met?
This device is manufactured by Hu-Friedy Mfg. Co., LLC, headquartered in Chicago, USA. The 4mm curved luxating elevator is classified as a Class I medical device according to current regulations. The manufacturer Hu-Friedy imposes high quality standards for the production of its surgical instruments. As a product distributed by Delynov, it meets the safety and performance requirements expected by health authorities for devices in this category. Healthcare professionals must refer to the indications, contraindications, and warnings provided by the manufacturer to ensure safe use in compliance with MDR standards.
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Specifications
| Manufacturer | Hu-Friedy |
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