Osteotomic Disk RA - JOTA (231DEF.RA.100) - Delynov
The Disque ostéotomique RA - JOTA is a medical device manufactured by le fabricant — Class IIa, CE marking CE0483.
- Compliance: Medical device Class IIa, CE marking CE0483.
- Manufacturer: le fabricant.
- Reference: 231DEF.RA.100.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the RA osteotomy disc - JOTA (231DEF.RA.100)?
The RA osteotomy disc, referenced under code 231DEF.RA.100 by the manufacturer JOTA AG, is a specialized rotary instrument for bone surgery. This dental surgical disc is designed to be mounted on a contra-angle (RA), allowing for precise manipulation during the cutting or rectification phases of dense structures. Marketed under the brand JOTA, this medical device meets the requirements of Class IIa. Its structure is specifically adapted to the constraints of oral surgery operating rooms, offering practitioners a reliable tool for interventions requiring effective rotary action on calcified tissues.
What are the clinical indications for this rotary disc?
Although the specific intended use is not detailed by the manufacturer in the data provided, this type of dental rotary disc is traditionally indicated for osteotomies, root separations, or remodeling of alveolar ridges. In implant surgery, it can be used for the preparation of bone flaps or the regularization of surfaces before implant placement. The use of this device from the brand JOTA must be validated by the expert practitioner, who remains solely responsible for the decision to use it based on the precise clinical case and the observed wear of the instrument.
What are the technical characteristics of this device?
The RA osteotomy disc (reference 231DEF.RA.100) is characterized by its compatibility with standard contra-angle (RA) systems. As a contra-angle diamond disc, it is designed to maintain optimal cutting performance. The manufacturer JOTA AG specifies that these instruments are delivered non-sterile and must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before the first use. Regular maintenance of associated equipment, such as washer-disinfectors and sterilizers, is crucial to guarantee the efficacy of the treatment for this instrument classified as semi-critical.
What are the contraindications for the use of this disc?
Specific contraindications are not exhaustively listed in the provided technical documentation. However, it is imperative not to use the product if it shows visible signs of wear or potential breakage. The manufacturer JOTA AG emphasizes that function and performance cannot be guaranteed if the products are worn, which could compromise patient safety. It is the surgeon's responsibility to evaluate the condition of the JOTA brand instrument before each intervention and to dispose of it preventively in case of doubt regarding its structural integrity or cutting capacity.
What are the maintenance and reuse precautions?
Instruments from the JOTA AG range are reusable, unless otherwise stated on the labeling. The reprocessing process is rigorous: after removal from the protective packaging, each disc must undergo effective cleaning and disinfection, which are sine qua non conditions for successful sterilization. The practitioner must use validated procedures and respect the approved parameters for each sterilization cycle. It is essential to avoid any cross-contamination during handling. The decision to reuse the device and the frequency of this reuse rest exclusively with the expert, based on the wear observed during bone surgery procedures.
Who is the manufacturer and what standards are respected?
The RA osteotomy disc is manufactured by JOTA AG, whose headquarters are located in Rüthi, Switzerland. This medical device complies with current European standards, bearing the CE0483 marking. It is classified as Class IIa according to medical device regulations. Compliance with these standards guarantees that the product meets strict safety and performance requirements for use in a surgical environment. As a distributor, Delynov ensures that these JOTA brand instruments respect the quality protocols necessary for the most demanding dental and oral surgery interventions.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | JOTA Professional Rotary Instruments |
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