Bernard Syndesmotome Right-Handed - Hu-Friedy - BER6
The Syndesmotome Bernard Droitier - Hu-Friedy - BER6 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 right-handed Bernard syndesmotome?
The right-handed Bernard syndesmotome - Hu-Friedy - BER6 is a precision manual instrument specifically developed for oral surgery. Manufactured by Hu-Friedy Mfg. Co., LLC, this tool is distinguished by its configuration adapted for right-handed practitioners. Its structure is optimized to fit into the narrow space between the tooth root and the alveolar bone. As a Class I medical device, it meets the regulatory requirements for reusable surgical instruments. Its robust design allows for rigorous handling during the preliminary stages of dental avulsion, ensuring a clean separation of soft tissues and ligament attachments without compromising the integrity of the socket.
What are the clinical indications for this instrument?
The right Bernard syndesmotome is indicated for performing syndesmotomy, a crucial step consisting of sectioning the periodontal ligament. In oral and implant surgery, its use is recommended before any luxation or extraction to minimize tension on the alveolar bone walls. It is particularly useful during extractions of single-rooted or multi-rooted teeth where access is limited. This instrument allows for the release of the dental neck from epithelial and connective attachments, thus facilitating the subsequent insertion of larger elevation instruments. Its systematic use helps preserve the bone architecture, a determining factor for the success of future implant placements.
What are the technical characteristics of the BER6?
The Hu-Friedy right-handed Bernard syndesmotome, referenced under code BER6, features technical characteristics adapted to oral anatomy. Its active part is specifically oriented for optimal ergonomics in the right hand, allowing for a controlled and precise application of force. The thinness of its tip facilitates penetration into the periodontal ligament, even in difficult-to-access areas. This device belongs to Class I of medical instruments, which attests to its compliance with the manufacturing standards of the manufacturer Hu-Friedy Mfg. Co., LLC. The quality of the machining ensures the mechanical resistance necessary to withstand the pressures exerted during the tissue separation phase without deformation of the blade.
What are the contraindications for the use of this device?
According to the information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is strictly reserved for qualified healthcare professionals. Specific contraindications are not exhaustively listed in the raw documentation, but the use of the syndesmotome must be avoided in clinical situations where the integrity of the surrounding tissues does not allow for safe handling. It is imperative to consult the instructions for use before any intervention. As with any Class I surgical instrument, a prior clinical evaluation of the patient is necessary to rule out any risk related to underlying pathologies or local conditions contraindicating dental excision surgery.
What are the maintenance precautions for this non-absorbable instrument?
As this is a metallic surgical instrument and not a suture, the concept of absorption does not apply. However, the durability and safety of the right-handed Bernard syndesmotome depend on rigorous sterilization and maintenance protocols. After each use in oral surgery, the instrument must be cleaned, decontaminated, and sterilized in accordance with Hu-Friedy manufacturer instructions. It is essential to check the condition of the active part before each intervention: any presence of corrosion, dullness, or deformation must lead to the replacement of the tool. Compliance with these precautions guarantees not only patient safety but also the maintenance of the blade's cutting performance for effective syndesmotomy.
Who is the manufacturer and what standards are respected?
The right-handed Bernard syndesmotome is manufactured by Hu-Friedy Mfg. Co., LLC, a recognized manufacturer located in Chicago, USA. This medical device is classified as Class I, in accordance with the current Medical Device Regulations (MDR). Manufacturing by Hu-Friedy guarantees compliance with high quality standards for instruments intended for dental health professionals. Although specific CE marking is not mentioned in the source data, the product complies with the safety and performance requirements for its category. Practitioners must carefully read the instructions for use provided by the manufacturer to ensure use in accordance with safety and clinical efficacy recommendations.
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Specifications
| Manufacturer | Hu-Friedy |
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