10 Pack of 1.0 mm Round Carbide Burs - Meisinger - (36TCT10016)

What is the 1.0 x 16mm Meisinger (36TCT10016) screw?

The 1.0 x 16mm screw developed by Meisinger is a high-precision osteosynthesis device designed for reconstructive surgery. Manufactured from grade 5 titanium alloy, this titanium implant screw is distinguished by its robustness and biocompatibility. It features a core diameter of 1.0 mm and a length of 16.0 mm, positioning it as a "rescue" screw within the Screw System TX Professional. Its design includes a low-profile head to minimize tissue bulk and a specific Torx tip. This technical drive guarantees secure retention of the screw in the driving tool while allowing the transmission of significant traction forces during clinical placement.

What are the clinical indications for this osteosynthesis screw?

This graft fixation screw is indicated for universal use in the context of pre-implantological bone augmentation. It is specifically intended for the fixation of cylindrical grafts, autologous bone blocks, and lamellae or external bone walls. Its use is validated for vertical, horizontal, or three-dimensional augmentation procedures. As a 1.0 mm diameter screw (TCT10), it is particularly useful when the transplant cannot be fixed with sufficient tensile strength using a smaller diameter screw (0.9 mm). It thus secures the surgical assembly in demanding clinical situations where primary graft stability is essential for future bone integration.

What are the technical characteristics of the Screw System TX?

The Meisinger osteosynthesis system relies on advanced mechanical properties to facilitate the practitioner's work. The use of grade 5 titanium alloy ensures the high mechanical strength essential for bone block stability. One of the major features is the integration of the Torx connection, which prevents accidental dislodgement of the screw during transfer to the surgical site and optimizes tightening torque. The Screw System TX Professional, which includes reference 36TCT10016, features extended screw lengths (13.0 mm and 16.0 mm) to adapt to various graft thicknesses. The reduced diameter and screw head geometry have been designed to provide increased comfort for both the user and the patient postoperatively.

What are the contraindications for the use of this device?

The use of these titanium screws is subject to compliance with general and local medical contraindications related to dental surgery. Absolute contraindications include the presence of active infections localized in the area intended for implantation. Furthermore, the device is contraindicated in patients with serious systemic or metabolic diseases, as well as those receiving medical treatments leading to progressive deterioration of bone structure. This particularly concerns patients on long-term corticosteroids, immunosuppressants, or bisphosphonate therapy. Uncontrolled diabetes also constitutes a major contraindication to the implementation of these bone augmentation protocols.

What are the precautions for use and implementation?

To ensure safe and effective use, the practitioner must strictly follow the placement protocols defined by Hager & Meisinger GmbH. Particular attention must be paid to rotation speeds during drilling and insertion. Recommended speeds, as well as maximum authorized speeds, are detailed in the technical documentation provided with the Bone Management® instrument kits. Failure to comply with these parameters may compromise fixation stability or damage the equipment. As this is a non-resorbable titanium alloy device, the screw must be removed after the healing and graft integration phase, generally during the implant placement phase, in accordance with best practices in implant surgery.

Who is the manufacturer and what standards are met?

This medical device is manufactured by Hager & Meisinger GmbH, a recognized company located in Neuss, Germany. The product benefits from rigorous compliance with current European standards for implantable medical devices. It is classified as Class IIb according to European regulations. Compliance is certified by the CE0044 marking. This certification guarantees that the 1.0 x 16mm screw meets the safety, performance, and manufacturing quality requirements imposed by health authorities. The traceability and quality of materials, notably the grade 5 titanium alloy used for these osteosynthesis screws, are subject to strict controls by the German manufacturer to ensure clinical reliability during interventions.

State of the art

Guided bone regeneration (GBR) in implantology relies on membrane fixation quality.