Gardner No. 2 Bone Chisel, Handle No. 524 - Hu-Friedy - Delynov

What is the #1/2 Orban DE Black Line gum knife?

The #1/2 Orban DE gum knife, part of the Hu-Friedy Black Line range, is a double-ended manual surgical instrument. This device is specifically structured for the manipulation of soft tissues in oral surgery. As a Hu-Friedy brand product, it benefits from the expertise of the manufacturer Hu-Friedy Mfg. Co., LLC. This knife is designed to offer a response adapted to the requirements of clinicians during gingival cutting phases. Its double-ended configuration allows for a versatile approach depending on the angulation required during the procedure.

What are the clinical indications for this gingivectomy knife?

This gingivectomy knife is primarily indicated for periodontal surgery procedures, notably gingivectomy and gingivoplasty. It is used by dental surgeons and periodontists for the precise excision of hypertrophied gingival tissues or to redefine the gingival architecture. Its design is particularly suited for reaching interdental and interproximal spaces, thus facilitating the removal of diseased or excess soft tissue. The use of this Hu-Friedy instrument is strictly reserved for qualified healthcare professionals operating in clinical or hospital environments.

What are the technical characteristics of this instrument?

The #1/2 Orban gum knife is distinguished by its DE (Double-Ended) configuration, offering two active ends on a single handle to optimize the surgical workflow. Although specific materials are not detailed in the source data, this instrument belongs to the CONSO category and is classified as a Class I medical device according to current regulations. It is manufactured by Hu-Friedy Mfg. Co., LLC, an entity recognized for the production of precision instruments. The Black Line series is often associated with specific finishes aimed at improving visibility and performance during the operative act.

What are the contraindications for the use of this device?

In accordance with the information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, specific contraindications are not listed exhaustively in the provided technical documentation. However, the use of this instrument is formally reserved for healthcare professionals who have received adequate training. General contraindications in oral surgery apply, such as use on tissues that do not present a clinical indication for excision or use by unqualified personnel. The instructions for use should be systematically referred to before any intervention.

What are the precautions for use and maintenance?

As a non-resorbable instrument intended for tissue cutting, precautions are based on the safe handling of sharp edges to avoid accidental damage to adjacent structures. The practitioner must ensure the perfect sterility of the instrument before use, in accordance with the disinfection and sterilization protocols for Class I medical devices. A visual inspection before each intervention is recommended to verify the integrity of the active ends. After use, cleaning must be rigorous to eliminate any biological residue before the next sterilization cycle.

Who is the manufacturer and what standards are respected?

The official manufacturer of this gum knife is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is listed under Class I, which implies compliance with the basic regulatory requirements for reusable manual surgical instruments. Although specific CE marking is not mentioned in the source data, the instrument meets the rigorous manufacturing standards imposed by US and international regulations for medical devices. Professionals must carefully read the instructions provided by Hu-Friedy to ensure compliant use.

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