Entaille Hu-Friedy Delynov - Instrument for Bone Grafting in Maxillofacial Surgery and Implantology

What is the Hu-Friedy n12 scalpel blade?

The n12 scalpel blade from the Hu-Friedy brand is a sterile, single-use cutting instrument, packaged in boxes of 100 units. This medical device is specifically designed for surgical interventions requiring great precision of movement. Manufactured by Hu-Friedy Mfg. Co., LLC, this blade features a distinctive curved shape, often called a sickle blade, which facilitates work in difficult-to-access anatomical areas. As a Class I consumable, it meets regulatory requirements for non-invasive or short-term invasive medical devices. Its structure allows for secure attachment to standard scalpel handles to guarantee optimal stability during the operative act.

What are the clinical indications for these scalpel blades 12?

In oral and implant surgery, the scalpel blade 12 is primarily indicated for making precise incisions in posterior or interproximal areas. Its concave curvature is ideal for cutting soft tissue during gingivectomies, muco-gingival surgeries, or for the excision of hyperplastic tissue. Practitioners also use this dental surgery blade for preparing implant sites and lifting full-thickness or partial-thickness flaps. Its tapered tip allows for controlled penetration into the sulcus, thus facilitating ligament detachment procedures or the resection of frenula hindering tissue mobility.

What are the technical characteristics of this device?

The n12 scalpel blades supplied by Hu-Friedy are characterized by a sharp edge located on the concave face of the blade. This technical specificity allows the surgeon to exert a pulling cutting force, which is particularly useful in narrow interdental spaces. The product is delivered in individual sterile packaging guaranteeing asepsis until the moment of use. Each box contains 100 pieces, with an expiration date clearly indicated to ensure rigorous stock management in the practice. The design respects the manufacturing standards of Hu-Friedy Mfg. Co., LLC, ensuring cutting consistency and compatibility with standard-sized scalpel handles used in daily practice.

What are the contraindications for the use of these blades?

According to information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of these blades is strictly reserved for qualified healthcare professionals. There are no specific medical contraindications listed other than use by untrained personnel. However, as with any sharp instrument, use is prohibited if the individual packaging is damaged, as the sterility of the device would no longer be guaranteed. The practitioner must evaluate the relevance of using the scalpel blade 12 in relation to the patient's specific anatomy and the nature of the intervention. It is imperative to respect disposal protocols for sharp and pointed objects after use to prevent any risk of blood exposure accidents.

What are the precautions for use and handling?

As a non-resorbable Class I device intended for cutting, precautions mainly concern safe handling. The insertion and removal of the n12 scalpel blade on the handle must be performed using a needle holder or suitable forceps to avoid any percutaneous injury. The practitioner must ensure not to exert excessive lateral pressure that could lead to blade breakage. Being a single-use product, any attempt at resterilization is prohibited, as it would alter the cutting properties and compromise patient safety. It is recommended to read the instructions for use provided by Hu-Friedy carefully before any clinical handling.

Who is the manufacturer and what standards are respected?

The official manufacturer of these devices is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. Hu-Friedy is a recognized manufacturer in the dental surgical instrumentation sector for its adherence to rigorous manufacturing protocols. These scalpel blades are classified as Class I medical devices. Compliance with the manufacturer's warnings and the indications mentioned on the labeling is essential to guarantee professional use conformity. Traceability is ensured by the lot number and the expiration date appearing on the packaging of each box of 100 pieces distributed by Delynov.

State of the art

Surgical medical consumables play a decisive role in operative safety.