SERALENE non-absorbable blue (5/0) DSS-13 needle 75 CM box of 24 sutures - Serag & Wiessner (LO10341L) - Delynov

What is SERALENE non-absorbable suture?

SERALENE from the brand Serag-Wiessner is a synthetic, monofilament, and non-absorbable surgical suture material. This Class III medical device is manufactured from polyvinylidene fluoride (PVDF), a polymer recognized for its high stability and biocompatibility. Dyed blue (solvent blue, colour index nº 61568) for better visibility during the surgical procedure, this thread features a smooth surface that minimizes trauma when passing through tissues. Its monofilament structure prevents capillarity and thus reduces the risk of bacterial colonization compared to braided threads, making it a preferred choice for oral cavity interventions.

What are the clinical indications for this device?

SERALENE suture is primarily indicated for soft tissue approximation and ligatures requiring the use of a non-absorbable thread. In oral and implant surgery, it is used for flap closure and mucosal management. Beyond dentistry, its properties allow its use in microsurgery, ophthalmology, as well as in the central circulatory and nervous systems. Polyvinyl fluoride threads can also serve as support threads or marking means. This product complies with the requirements of the European Pharmacopoeia monograph concerning sterile non-absorbable sutures (fila non resorbilia sterilia).

What are the technical characteristics of the DSS-13 needle?

This reference LO10341L is equipped with a DSS-13 needle. According to technical nomenclature, the DSS code corresponds to a 3/8 circle curvature needle with a reverse cutting triangular tip. This geometry is specifically designed to be atraumatic, facilitating penetration into delicate tissues and thin mucous membranes without the risk of lateral tearing. The number 13 indicates a needle length of 13mm, a dimension adapted to the restricted spaces of the oral cavity. The associated thread has a 5/0 (USP) calibre and a length of 75cm, offering sufficient maneuverability for precision sutures.

What are the contraindications for the use of this suture?

The use of SERALENE is strictly contraindicated in patients with a known hypersensitivity or allergy to polyvinylidene fluoride or the dye solvent blue (colour index nº 61568). Furthermore, as with any implanted foreign body, the manufacturer Serag-Wiessner GmbH & Co. KG specifies that this device may promote stone formation in case of prolonged contact with the urinary or biliary tracts. The choice of material must always be made by the practitioner taking into account the specific characteristics of the material and the technical requirements of the procedure.

What are the precautions related to the non-absorbable nature of the thread?

As SERALENE is a non-absorbable monofilament suture, it does not undergo degradation by hydrolysis or proteolysis. It therefore permanently maintains its tensile strength in the tissues. In oral surgery, this implies that the sutures must be removed by the practitioner once healing of the wound edges is achieved. Its PVDF monofilament structure offers excellent knot security, although the very smooth surface of the thread requires a rigorous knotting technique to avoid any slipping. It is recommended to carefully read the instructions to adapt the suturing technique to the mechanical characteristics of polyvinylidene fluoride.

Who is the manufacturer and what standards are respected?

SERALENE suture is manufactured by Serag-Wiessner GmbH & Co. KG, a recognized manufacturer based in Naila, Germany. This medical device is certified CE1014 and classified as Class III, meeting the strictest regulatory requirements for surgical implants. The product is delivered in a box of 24 sterile sutures, each unit consisting of a 75cm thread and a high-quality surgical steel needle. Compliance with European Pharmacopoeia standards guarantees the safety and performance of the material for soft tissue approximation procedures in hospital settings or specialized clinics.

State of the art

Modern synthetic sutures - absorbable or non-absorbable - are central to wound healing in oral surgery. Recent advances focus on reducing post-operative infections.