Diamond FG Instrument x5 - JOTA (859.FG.010) by Delynov
The x5 instrument diamant FG - 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: 859.FG.010.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the FG - JOTA (859.FG.010) diamond instrument?
The FG 859.010 diamond instrument, distributed by Delynov under the JOTA JOTA, is a high-precision rotary tool intended for turbines. This dental diamond instrument is designed with a working part coated with diamond particles selected for their cutting efficiency. Its structure is adapted to fit into high-speed contra-angles (Friction Grip). This medical device belongs to the INSTRU category and meets the quality requirements for dental preparation procedures in the office. Its design allows for optimized thermal management and debris evacuation during clinical use.
What are the clinical indications?
This dental diamond instrument is primarily indicated for dental preparation, particularly for cavity preparation or the shaping of prosthetic abutments. As a diamond turbine bur, it is used by dental surgeons for the selective removal of hard tooth tissues (enamel and dentin). It can also be used during the adjustment procedures of restorative materials. The use of this diamond turbine bur is reserved for qualified healthcare professionals, ensuring a precise and secure intervention in accordance with current clinical protocols.
What are the technical characteristics of this instrument?
The 859.FG.010 instrument from the JOTA JOTA is characterized by a standard FG (Friction Grip) type shank, compatible with turbines and high-speed contra-angles. Its technical reference 859.FG.010 defines a specific geometry for targeted clinical movements. The manufacturer JOTA AG specifies that these instruments are metallic or plastic and require rigorous verification of cleaning agent compatibility. Material resistance is a key point, involving strict compliance with concentrations and temperatures during ultrasonic or manual cleaning to maintain the integrity of the dental diamond bur.
What are the contraindications for use?
There are no specific medical contraindications listed by the manufacturer JOTA AG outside of standard safety protocols. However, use is contraindicated if the device shows signs of wear or possible breakage. The physician or expert user is solely responsible for the decision to reuse the product based on its condition. In case of doubt regarding the integrity of the diamond turbine bur, it is strongly recommended to discard the product prematurely to avoid any risk of performance failure or breakage in the mouth.
How is reprocessing carried out and what are the precautions?
All instruments from the JOTA JOTA are classified as semi-critical and must undergo a complete cycle of cleaning, disinfection, and sterilization before each application. For the first use, removal of the protective packaging must be followed by disinfection and sterilization after packaging. The use of sterile demineralized or low-contamination water is required. The practitioner must ensure the validity of the procedures (maintained sterilizer, approved parameters). Reuse depends on the practitioner's expertise, who must assess wear; the manufacturer no longer guarantees maximum safety if the products are worn.
Who is the manufacturer and what standards are respected?
The official manufacturer is JOTA AG, located in Rüthi, Switzerland. This medical device is classified as Class IIa and bears the CE0483 marking, guaranteeing its compliance with European regulatory requirements. The manufacturer emphasizes that these reprocessing instructions apply to its entire range distributed by Delynov. The responsibility for sterility rests with the user, who must ensure that cross-contamination is avoided and scrupulously follow the maintenance instructions for cleaning and sterilization devices to ensure the performance of this dental diamond instrument.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | JOTA Professional Rotary Instruments |
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