Surgical Kit for Alveoloplasty (1471) JOTA - Delynov

What is the Alveoloplasty surgical kit (1471) JOTA?

The alveoloplasty surgical kit (1471) developed by the brand JOTA is a complete set of rotary or manual instruments intended for dental surgeons and implantologists. This kit, identified under reference 1471, is specifically designed for bone remodeling procedures. Components are manufactured by JOTA AG in Switzerland, a manufacturer recognized for the quality of its medical devices. These instruments are delivered non-sterile and require a full cycle of cleaning, disinfection, and sterilization before their first use. They are designed to be reusable, subject to a rigorous verification of their wear status by the responsible practitioner.

What are the clinical indications for this kit?

This alveoloplasty surgery kit is indicated for all procedures requiring a modification of the morphology of the alveolar ridge. It is mainly used during simple or complex alveoloplasties, aiming to eliminate bone spicules after multiple extractions or to regularize exostoses hindering the wearing of prostheses. In pre-implant surgery, these dental alveoloplasty instruments allow for the preparation of a homogeneous bone site. The manufacturer JOTA AG specifies that the use of these devices is reserved for experts capable of assessing product wear, as performance and safety directly depend on the integrity of the material used during the surgical act.

What are the technical characteristics of this device?

The alveoloplasty instrument kit consists of metallic or plastic elements meeting strict standards of material resistance. As a Class IIa medical device, it benefits from the CE0483 marking, guaranteeing its compliance with European regulatory requirements. The instruments are classified as semi-critical, which imposes a rigorous reprocessing protocol. The brand JOTA emphasizes that the compatibility of cleaning agents is crucial, particularly for ultrasonic cleaning where foam formation must be avoided. Users must respect the concentrations and temperatures recommended by the manufacturer to preserve the physical properties of the metallic instruments.

What are the contraindications for the use of these instruments?

The main contraindications lie in the state of wear or potential breakage of the products. The manufacturer JOTA AG stipulates that if the labeling contains specific contradictory information, reuse may be prohibited. There are no absolute medical contraindications mentioned other than risks related to improper sterilization or the use of dull instruments that could compromise patient safety. The practitioner is solely responsible for the decision to reuse the product based on the observed wear. In case of doubt regarding the integrity of a kit instrument, it is strongly recommended to dispose of it prematurely and replace it to maintain an optimal performance level.

What are the maintenance and sterilization precautions?

The sterility of the instruments is the responsibility of the practitioner. The protocol requires the use of validated procedures for cleaning, disinfection, and sterilization. It is imperative to use sterile demineralized or low-contamination water (max. 10 germs/ml) with low endotoxin content for the final rinse. Cleaning devices (washer-disinfector, sterilizer) must be maintained and checked regularly. The alveolar surgery kit must be cleaned after removal from the initial protective packaging, then wrapped before autoclaving. Compliance with validated parameters at each cycle is essential to guarantee effective disinfection before any clinical application.

Who is the manufacturer and what standards are respected?

The kit is manufactured by JOTA AG, located in Rüthi, Switzerland. This medical device is certified Class IIa under the CE0483 marking. The brand applies rigorous manufacturing standards for its entire range distributed by Delynov. The reprocessing instructions provided by the manufacturer apply to all medical devices in their catalog, unless an exception is mentioned. As a manufacturer, JOTA AG guarantees the operation and safety of the products as long as they do not show a maximum degree of wear. Compliance with detergent concentrations and soaking times, in accordance with the chapter on material resistance, is essential to maintain compliance with current safety standards.

State of the art

Single-use sterile surgical kits significantly reduce intraoperative contamination.