Composite instrument #8A #6S XTS handle
The Instrument à composite #8A manche #6S XTS is a medical device manufactured by le fabricant.
- Compliance: Medical device Class I.
- Manufacturer: le fabricant.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the #8A composite instrument with #6S XTS handle?
The #8A composite instrument with #6S XTS handle is a specialized manual device designed by the manufacturer for the manipulation of restorative materials. Marketed under the brand Hu-Friedy, this tool belongs to the INSTRU category. It consists of a specific working part (#8A) and an ergonomic handle of the #6S XTS type. This device is specifically developed to meet the requirements of dental surgeons during the modeling phases. As a Class I product, it complies with basic safety standards for non-invasive instruments used in dental practices. Its design aims to facilitate the transfer and adaptation of composite onto dental structures without altering the physical properties of the material used.
What are the clinical indications?
The clinical indications for this posterior composite instrument primarily concern direct restorations in conservative dentistry. It is used for shaping composites in posterior sectors, where access and visibility require adapted instrumentation. The instrument allows for condensing, sculpting, and smoothing the restorative material before its polymerization. According to the information provided by the manufacturer Hu-friedy, the use of this device is strictly reserved for qualified healthcare professionals. It is involved in protocols for treating caries, reconstructing dental walls, or adjusting occlusal anatomy to ensure optimal masticatory function and the longevity of the restoration.
What are the technical characteristics?
The #8A composite instrument with #6S XTS handle from the brand Hu-Friedy is distinguished by its specific technical reference that defines its geometry. The #6S XTS handle is designed to offer a stable grip, reducing fatigue during prolonged interventions. The #8A working part is optimized for work on composites, minimizing material adhesion to the instrument, which is crucial for obtaining smooth surfaces. This product is classified as Class I according to medical device regulations. Manufacturing is carried out by the manufacturer Hu-friedy, located in Chicago, USA. Every technical detail is designed to ensure precise transmission of force during the application of filling materials.
What are the contraindications for use?
The contraindications mentioned by the manufacturer for this instrument from the brand Hu-Friedy stipulate that its use is exclusively reserved for healthcare professionals. Although the source text does not list specific pathologies prohibiting its use, it is imperative to respect the intended use defined by Hu-friedy. Any use outside the framework of professional dentistry or by untrained personnel is prohibited. Reference should systematically be made to the instructions for use before any handling. As with any Class I instrument, a visual inspection before use is necessary to ensure the integrity of the device and avoid any risk related to premature wear or structural damage.
What are the maintenance and durability precautions?
As a non-resorbable instrument intended for repeated use after sterilization, strict precautions must be observed. Although the composition specifications are not detailed in the source data, this type of Class I instrument requires a rigorous cleaning and disinfection protocol in accordance with Hu-friedy guidelines. It is essential to read the instructions carefully for compatible sterilization cycles and to avoid any degradation of the #6S XTS handle or the #8A tip. Inadequate maintenance could compromise the performance of this posterior composite instrument. The durability of the product depends directly on compliance with the manufacturer's warnings and careful handling by the practitioner.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is Hu-friedy, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is listed under Class I, confirming its compliance with the regulatory requirements applicable to this category of surgical instruments. The brand Hu-Friedy ensures the distribution of this high-precision equipment. The manufacturer emphasizes that the product is reserved for healthcare professionals and that the instructions must be consulted before any use. Compliance with these standards ensures that the instrument meets the safety and performance standards required for dental and restorative surgery interventions, thus ensuring constant reliability during its integration into the clinical workflow.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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