Osteotomy disc RA - JOTA (231DEF.RA.130) - Delynov
The Ostéotomie disc 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.130.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the RA Osteotomy disc - JOTA (231DEF.RA.130)?
The RA Osteotomy disc, bearing technical reference 231DEF.RA.130, is a rotary instrument from the JOTA range intended for oral surgical procedures. This device is a diamond disc designed to be mounted on a contra-angle (RA). Its structure incorporates metal or plastic components selected for their resistance to cleaning and sterilization processes. As a product in the CONSO category, it is delivered non-sterile and requires a complete reprocessing protocol before its first use in the practice or operating room. The manufacturing quality of JOTA ensures compliance with practitioner requirements for fine bone cutting procedures.
What are the clinical indications for this diamond disc?
This surgical diamond disc is primarily indicated for osteotomy and bone sectioning procedures. It is used by dental surgeons and implantologists to perform precise cuts in hard tissues. The use of this dental osteotomy disc is part of various clinical protocols where contra-angle rotary instrumentation is required. According to JOTA AG manufacturer guidelines, the practitioner is solely responsible for the decision to use or reuse the product based on the specific clinical case. The wear condition of the disc should be checked before each procedure to guarantee the performance and safety of the surgical act, particularly during bone separation or remodeling phases.
What are the technical characteristics of the 231DEF.RA.130 instrument?
The 231DEF.RA.130 device is characterized by its compatibility with standard contra-angle (RA) systems. This contra-angle diamond disc is manufactured from metallic or plastic materials resistant to ultrasonic cleaning agents and specific detergents, provided that the manufacturer's concentration and temperature recommendations are followed. The maintenance process requires the use of sterile demineralized or low-contamination water for rinsing to avoid any deposits. The JOTA instrument design allows for fluid integration into the surgical workflow, while respecting the validated sterilization parameters for medical devices of its class.
What are the contraindications and limitations of use?
There are no specific medical contraindications listed by the manufacturer other than the rules of prudence related to the instrument's condition. Use is contraindicated if the disc shows visible signs of wear or potential breakage, as the manufacturer JOTA AG cannot guarantee the performance of failing or worn products. The expert physician is responsible for evaluating the suitability of the device before each use. In case of doubt regarding the integrity of the disc, it is formally recommended to dispose of the product earlier than planned and replace it with a new instrument to maintain a maximum degree of safety for the patient.
What are the precautions related to reprocessing and reuse?
This JOTA device is reusable, unless otherwise stated on the labeling. The reprocessing protocol is rigorous: mandatory cleaning and disinfection after removal from protective packaging for new products, followed by sterilization after packaging. The practitioner must use validated procedures and ensure that sterilization devices (autoclaves) are checked regularly. It is crucial to avoid any contamination during the treatment cycle. The use of freshly prepared solutions and compliance with the soaking times recommended by the detergent manufacturer are essential to preserve the material resistance of the disc and ensure total sterility before the surgical act.
Who is the manufacturer and what standards are respected?
The RA Osteotomy disc is manufactured by JOTA AG, headquartered in Rüthi, Switzerland. This medical device belongs to Class IIa and bears the CE0483 marking, certifying its compliance with current European regulatory requirements. As a recognized manufacturer, JOTA AG provides detailed instructions for the reprocessing of its instruments, which apply to its entire range distributed by Delynov. Compliance with these standards ensures that the instrument meets the safety and performance standards required for oral surgery. Responsibility for sterility and maintenance rests with the user, who must apply the approved parameters to each sterilization cycle.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | JOTA Professional Rotary Instruments |
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