Instrument #117 composite with handle #6 for anterior teeth - Hu-Friedy - Delynov
The Instrument à composite #117 manche #6 antérieur - Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.
- Compliance: Medical device Class I.
- Manufacturer: Hu-Friedy Mfg. Co., LLC.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the composite instrument #117 handle #6 anterior - Hu-Friedy?
The composite instrument #117 handle #6 anterior, designed by the manufacturer Hu-Friedy Mfg. Co., LLC, is a manual device specifically dedicated to aesthetic restorations. This tool from the INSTRU category consists of a working part optimized for the anterior sector and a #6 type handle, recognized for its diameter promoting a stable grip. As a Class I device, it meets the basic regulatory requirements for non-invasive or short-term invasive instruments. Hu-Friedy's manufacturing quality ensures precise handling of restorative materials during dental composite shaping, allowing for smooth surfaces and natural anatomical contours on front teeth.
What are the clinical indications?
This instrument is indicated for restorative dentistry procedures involving the application and shaping of composite resins in the anterior block. It is used by dental surgeons for the filling of Class III, IV, and V cavities, as well as for the creation of direct veneers. Its geometry is designed to facilitate access to the interproximal and cervical areas of incisors and canines. The intended use, as defined by Hu-Friedy, concerns exclusively qualified healthcare professionals operating in a clinical environment for conservative or aesthetic care requiring great shaping finesse.
What are the technical characteristics?
The #117 instrument is distinguished by its #6 handle, a standardized format at Hu-Friedy offering an optimal balance to reduce fatigue during prolonged shaping sessions. The active part is specifically configured for the anterior sector, allowing delicate manipulation of composite masses without excessive adhesion to the material, which is crucial for dental composite shaping. This device is classified as Class I according to current regulations. It is designed to withstand standard sterilization cycles in the dental office, in accordance with the instructions provided by Hu-Friedy Mfg. Co., LLC, thus guaranteeing longevity and consistent safety of use.
What are the contraindications for use?
According to data provided by the manufacturer Hu-Friedy, the use of this instrument is strictly reserved for trained healthcare professionals. Although the raw MDR text does not list specific medical contraindications related to patient pathology, the use of the instrument must be prohibited for any application other than that intended by the manufacturer. It must not be used if the instrument shows signs of degradation or corrosion, as this could compromise the integrity of the restoration or patient safety. Practitioners must carefully consult the instructions before any use to ensure compliance with hygiene and safety protocols.
What are the maintenance and handling precautions?
As a non-resorbable and reusable instrument, the Hu-Friedy composite instrument #117 requires a rigorous decontamination and sterilization protocol after each intervention. It is imperative to read the instructions carefully before use to learn the cleaning methods recommended by Hu-Friedy Mfg. Co., LLC in order to preserve the surface condition of the working ends. Careful handling is required to avoid damaging the fine tips, which could alter the quality of dental composite shaping during future interventions. Storage must be in a dry and clean environment, in accordance with Class I standards.
Who is the manufacturer and what standards are respected?
The official manufacturer of this instrument is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St., Chicago, IL 60618, USA. Hu-Friedy is a recognized manufacturer in the dental sector for the quality of its surgical and restorative devices. This product is listed as a Class I medical device. Compliance with manufacturing standards by Hu-Friedy ensures practitioners a reliable tool that complies with regulatory requirements for office use. As indicated on the labeling, this equipment is reserved for healthcare professionals and its use requires prior reading of the technical instructions attached by the manufacturer.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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