Elevator number 9R with handle number 503 - Hu-Friedy - Delynov

What is the Hu-Friedy #9R elevator #502 handle?

The #9R elevator with #502 handle is a precision manual instrument manufactured by Hu-Friedy Mfg. Co., LLC. This device belongs to the category of surgical instruments (INSTRU) and is specifically designed for oral surgery interventions. Its structure includes an active part referenced #9R mounted on an ergonomic handle of type #502. As a Class I device, it meets standard regulatory requirements for non-invasive or transient invasive surgical instruments. The Hu-Friedy brand ensures rigorous manufacturing to meet the needs of practitioners in implantology and dental surgery.

What are the clinical indications?

This instrument is indicated for dental extraction procedures, particularly for the luxation of teeth or roots before the use of forceps. The #9R elevator facilitates the rupture of periodontal ligament fibers and the expansion of the bony socket. It is particularly useful during extractions of residual roots or within the framework of pre-implant surgeries requiring careful management of alveolar structures. Its use is strictly reserved for qualified healthcare professionals, in accordance with the directives of the manufacturer Hu-Friedy located in Chicago, USA.

What are the technical characteristics?

The elevator consists of a shank and a #9R active part integrated with a #502 handle. Although the exact composition is not specified in the provided technical documentation, Hu-Friedy instruments are recognized for their industrial manufacturing quality. The #502 handle is designed to provide a grip adapted to the rotation and leverage movements necessary in surgery. This device is classified as Class I according to current regulations. It is imperative to refer to the instructions for use for cleaning and sterilization protocols before any clinical intervention.

What are the contraindications for use?

According to information from the manufacturer Hu-Friedy Mfg. Co., LLC, specific contraindications are not exhaustively listed in the raw MDR text, other than the obligation of use by a healthcare professional. However, generally in oral surgery, the use of this elevator may be contraindicated in case of risk of injury to critical adjacent anatomical structures (nerves, sinuses) if space is insufficient or if bone density does not allow for secure support. It is the practitioner's responsibility to evaluate clinical risks before using this Class I instrument.

What are the precautions for use and maintenance?

The #9R elevator #502 handle is a reusable instrument that requires rigorous management. Before the first use and after each intervention, it must be cleaned, disinfected, and sterilized in accordance with the instructions from the manufacturer Hu-Friedy. The practitioner must inspect the instrument to detect any sign of wear or deformation of the #9R active part that could compromise leverage efficiency or patient safety. As indicated by Hu-Friedy, it is crucial to read the instructions carefully before use to ensure compliance with asepsis and maintenance protocols.

Who is the manufacturer and what standards are respected?

The official manufacturer of this instrument is Hu-Friedy Mfg. Co., LLC, headquartered at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is listed under Class I. Hu-Friedy's compliance with manufacturing standards ensures that the instrument conforms to safety requirements for medical devices intended for healthcare professionals. Although specific CE marking is not mentioned in the source data, the Class I classification indicates compliance with self-certification processes for surgical instruments in this category.

State of the art

Specialized surgical instrumentation is evolving towards ergonomic designs.