2 x Strawberry Round Balls C141F.HP.018 for Handpiece - JOTA - Delynov
The x2 fraises boules C141F.HP.018 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.018 round bur from the brand JOTA?
The C141F.HP.018 round bur, distributed by Delynov, is a high-precision rotary instrument designed by the manufacturer JOTA AG. This carbide HP bur is distinguished by its spherical head adapted for work on hard tissues. Its structure is optimized for use on a handpiece (HP), offering the stability necessary during bone clearance phases. As a tungsten carbide round bur, it ensures significant durability and wear resistance for demanding practitioners. This medical device from the brand JOTA is delivered in a lot of two units, allowing for efficient rotation of instrumentation within the oral surgery practice.
What are the clinical indications for this surgical bur?
Although the specific intended use is not detailed in the raw MDR data, this HP bone bur is traditionally indicated for oral surgery procedures requiring controlled bone subtraction. It is used during osteotomy, the creation of access wells, or the regularization of bone volumes before implant placement. Its design makes it a tool of choice for dental surgeons and implantologists performing alveoloplasties or complex extractions. The brand JOTA guarantees the performance of its instruments as long as they do not show signs of excessive wear, thus ensuring the safety of clinical interventions.
What are the technical characteristics of this instrument?
The C141F.HP.018 model is a round HP bur 1 8mm specifically designed to fit standard handpieces. Manufactured by JOTA AG in Switzerland, it benefits from rigorous engineering. The reference indicates a working diameter of 1.8 mm, ideal for precision interventions in narrow areas. The instruments are classified as semi-critical, which imposes a strict reprocessing protocol. They must be cleaned, disinfected, and sterilized before the first use and after each subsequent application. Maintaining cutting performance directly depends on compliance with the cycle parameters validated by the practitioner during sterilization.
What are the contraindications for the use of this device?
According to information from the manufacturer JOTA AG, there are no specific contraindications listed other than wear or eventual breakage of the product. However, the physician or expert using the device is solely responsible for the decision to reuse the instrument or not based on its observed condition. It is strongly recommended to discard and replace products as soon as a doubt about their physical integrity arises. Using a dull or damaged bur can compromise patient safety and the effectiveness of the surgical procedure, as the manufacturer cannot guarantee optimal functioning under these degradation conditions.
What are the precautions related to reprocessing and reuse?
Instruments in the JOTA range are reusable unless otherwise stated on the labeling. Responsibility for sterility lies with the practitioner, who must implement validated cleaning and disinfection (WD) procedures before sterilization. Effective cleaning is the sine qua non condition for successful sterilization. It is imperative to remove the protective packaging before the first treatment cycle. The manufacturer emphasizes that devices must be maintained regularly and that sterilization parameters must be rigorously applied at each cycle to avoid cross-contamination and maintain the mechanical properties of the round bur 1 8mm.
Who is the manufacturer and what standards are respected?
These burs are manufactured by JOTA AG, headquartered in Rüthi, Switzerland. This medical device belongs to Class IIa, in accordance with current regulations. It bears the CE0483 marking, guaranteeing its compliance with European safety and performance requirements. As a product distributed by Delynov, it meets the high standards required for dental and implant surgery. Compliance with the Class IIa classification ensures healthcare professionals that the instrument has undergone rigorous evaluations by notified bodies, confirming its reliability for repeated clinical use after appropriate reprocessing.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | JOTA Professional Rotary Instruments |
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