Lame Removal Hu-Friedy - Delynov

What is the Hu-Friedy 12d scalpel blade?

The 12d scalpel blade developed by Hu-Friedy is a sterile single-use cutting instrument, specifically designed for oral surgery interventions. This device comes in the form of a dental surgery blade with a characteristic double curvature, allowing precise manipulation in hard-to-reach areas. Packaged in boxes of 100 units, each 12d scalpel blade is subject to a strict expiration date to guarantee the integrity of the cutting edge and microbiological safety during the surgical procedure. As a product of the Hu-Friedy brand, it meets the manufacturing requirements of a recognized manufacturer in the global dental sector.

What are the clinical indications for this dental surgery blade?

The use of the 12d surgical scalpel blade is primarily indicated in periodontology and implantology procedures. Its geometry is ideal for performing sulcular incisions, gingivectomies, or for the preparation of full-thickness or partial-thickness flaps. It is particularly effective for reaching the distal surfaces of the last molars and narrow interdental spaces. In implant surgery, it allows for a precise cut of keratinized tissues around healing abutments or during the implant uncovering phase. This type of dental surgery scalpel blade ensures a clean incision, promoting optimal healing of peri-implant and periodontal soft tissues.

What are the technical characteristics of the 12d scalpel blade?

The 12d scalpel blade is distinguished by its tapered profile and its double cutting edge on the curved part, which differentiates it from standard blades such as the No. 15. This technical design allows the surgeon to operate with a pulling or pushing motion depending on the anatomical constraints encountered. Manufactured by Hu-Friedy Mfg. Co., LLC, it is designed to fit on standard scalpel handles compatible with small blades. The quality of the sharpening guarantees tissue penetration with minimal resistance, thus reducing mechanical trauma to the incision edges. Each unit is individually wrapped to maintain sterility until use at the chairside.

What are the contraindications for the use of this device?

The specific contraindications mentioned by the manufacturer Hu-Friedy relate primarily to the regulatory framework of use. This device is strictly reserved for qualified health professionals in dental and oral surgery. It must not be used if the individual packaging is damaged, as sterility would no longer be guaranteed. Although the raw MDR text does not list specific physiological contraindications, it is imperative to respect standard asepsis protocols. Using a blade beyond its expiration date is prohibited, as this can alter the mechanical properties of the steel and compromise patient safety. A prior clinical evaluation must validate the patient's suitability to undergo surgery.

What are the precautions for use and handling?

Handling the 12d scalpel blade requires particular attention to avoid accidental percutaneous injuries. Mounting and removing the blade from the handle must imperatively be carried out using a needle holder or specific forceps, in accordance with good safety practices in the operating room. As it is a non-resorbable and sharp device, it must be disposed of immediately after use in a container for sharps (OPCT). It is recommended to read the instructions carefully before use. The precision of the dental surgery scalpel blade also depends on the stability of the handle used, thus guaranteeing total control of the surgical gesture during delicate incisions.

Who is the manufacturer and what standards are respected?

These blades are manufactured by Hu-Friedy Mfg. Co., LLC, headquartered in Chicago, USA. The device is regulatory classified as Class I, which corresponds to medical devices presenting a low potential risk, but whose manufacturing follows rigorous quality protocols. Although specific CE marking is not detailed in the sources provided, the product respects the manufacturing standards of Hu-Friedy, a historical player in the sector. The Class I mention confirms that the product meets the basic requirements for non-invasive or temporary invasive surgical instruments. Lot and expiration date tracking by Delynov ensures traceability in line with the needs of dental surgery and implantology practices.

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