2 strawberries balls C141F.HP.023 for handpiece - JOTA - Delynov
The x2 fraises boules C141F.HP.023 pour pièce à main - 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.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the C141F.HP.023 JOTA round bur?
The C141F.HP.023 round bur from the JOTA Brand is a rotary instrument in the CONSO category intended for oral and implant surgery. This device, identified as a carbide hp bur, is designed to be mounted on a handpiece. Its metallic structure is developed by the manufacturer JOTA AG to meet the requirements of clinical interventions requiring material removal or bone preparation. It is delivered in packaging of two units, allowing for optimal stock management at the practice. This Brand product is part of a range of rotary instruments recognized for their application in demanding surgical environments.
What are the clinical indications for this surgical carbide bur?
This surgical carbide bur is indicated for oral and maxillofacial surgery procedures requiring the use of a handpiece. It is primarily used for bone resection, alveoloplasty, or site preparation during pre-implant surgeries. According to the instructions from the manufacturer JOTA AG, these instruments are reusable unless otherwise stated on the specific labeling. The choice to use this dental hp round bur rests on the decision of the physician or expert, who is solely responsible for evaluating product wear and the relevance of its reuse depending on the specific clinical case encountered.
What are the technical characteristics of the hp 2 3mm round bur?
The hp 2 3mm round bur features specific technical characteristics for use on a handpiece (HP). It is manufactured from metallic materials resistant to cleaning and sterilization processes. As a Class IIa device, it meets strict safety standards, marked by the CE0483 certification. The manufacturer specifies that the compatibility of cleaning agents, particularly when using ultrasonics, is essential to maintain the integrity of the instrument. It is imperative to respect the concentrations, temperatures, and soaking times recommended by the detergent manufacturers to preserve the cutting properties of this carbide hp bur.
What are the contraindications for the use of this device?
There are no specific medical contraindications listed by the manufacturer JOTA AG in the provided documentation, beyond the fundamental principles of surgical prudence. However, use is contraindicated if the product shows signs of wear or potential breakage, as the manufacturer cannot guarantee maximum performance and safety if the instruments are degraded. In case of doubt regarding the condition of the carbide round bur, it is strongly recommended to dispose of the product prematurely and replace it to avoid any risk during the operative procedure.
What are the precautions related to reuse and reprocessing?
Although JOTA Brand instruments are considered reusable, they must imperatively undergo a complete cycle of cleaning, disinfection, and sterilization before each application, including before the first use. They are classified as semi-critical instruments. The practitioner must use validated procedures for cleaning and sterilization, ensuring the use of sterile demineralized or low-contamination water (max. 10 germs/ml) with low endotoxin content. The responsibility for the sterility of the instruments lies with the user, who must ensure the proper maintenance of sterilization devices and compliance with approved parameters.
Who is the manufacturer and what standards are respected?
The official manufacturer of these burs is JOTA AG, located at Hirschensprungstrasse, 29464 Rüthi, Switzerland. This medical device complies with current regulations, classified as Class IIa and bearing the CE0483 marking. These certifications guarantee that the burs meet the safety and performance requirements defined for rotary surgical instruments in Europe. Compliance with these standards ensures practitioners that each dental hp round bur distributed by Delynov follows controlled and documented manufacturing processes by a manufacturer recognized in the field of medical rotary technologies.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | JOTA Professional Rotary Instruments |
| Tags | |
|---|---|
| Tags | |