Cement Spatula - Hu-Friedy - Delynov
The Spatule à ciment - 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 Hu-Friedy - Delynov cement spatula?
The Hu-Friedy cement spatula is a manual instrument specifically designed for the clinical environment. Manufactured by Hu-Friedy Mfg. Co., LLC, this spatula belongs to the category of Class I consumables and instruments. It features a structure adapted for mixing chemical components used during restoration or sealing phases. Its design allows for easy handling of pastes and powders, ensuring a fluid preparation of materials before their application in a cavity or on prosthetic elements. As a Class I medical device, it meets the quality requirements of a recognized manufacturer in the field of surgical and dental instrumentation.
What are the clinical indications?
The clinical indications for this instrument primarily concern the preparation phase of sealing and restorative materials. In oral surgery and restorative dentistry, the use of a dental cement mixer is required for the amalgamation of zinc oxide-eugenol cements, glass ionomer cements, or definitive sealing cements. The instrument allows for the manipulation of materials on a glass slab or mixing pad to achieve optimal viscosity according to the planned procedure, whether it is a crown placement, a bridge, or a protective base under a restoration. Its use is strictly reserved for qualified healthcare professionals.
What are the technical characteristics?
The cement spatula produced by Hu-Friedy is a Class I instrument whose geometry is optimized for mixing. Although precise composition specifications are not detailed in the source data, the instrument is designed to withstand the mechanical stresses associated with mixing viscous substances. Its shape allows for the application of adequate pressure to crush powder particles into the liquid, ensuring a homogeneous chemical reaction. The Hu-Friedy reference guarantees a device compliant with the manufacturing standards of Hu-Friedy Mfg. Co., LLC, based in Chicago, USA. It is an initially non-sterile tool, intended to be integrated into the standard disinfection and sterilization protocol of the practice.
What are the contraindications for use?
According to the information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, there are no specific medical contraindications listed for this Class I instrument, other than its exclusive use by healthcare professionals. However, standard use protocols must be followed to avoid any cross-contamination. Use of the instrument should be avoided if it shows signs of structural degradation that could alter the quality of the mixture or pose a risk to the patient. It is imperative to carefully read the instructions for use and respect the warnings from the manufacturer located at 3232 N. Rockwell St. Chicago, Il 60618 USA before any clinical handling.
How is maintenance performed and what are the precautions?
As it is a non-resorbable and reusable instrument, precautions focus on the decontamination cycle. After each use as a dental cement mixer, the spatula must be cleaned immediately to prevent materials from hardening on the working surfaces, which could compromise future use or the integrity of the instrument. The professional must follow the current cleaning, disinfection, and sterilization procedures for Class I devices. Particular attention must be paid to the total removal of cement residues. Compliance with Hu-Friedy manufacturer instructions is essential to maintain the long-term performance of the instrument in a surgical setting.
Who is the manufacturer and what standards are respected?
The device is manufactured by Hu-Friedy Mfg. Co., LLC, with its headquarters located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This product is classified as a Class I medical device, in accordance with current regulations. As a recognized manufacturer, Hu-Friedy ensures the traceability and compliance of its instruments intended for healthcare professionals. Although specific CE marking is not mentioned in the source documentation, the Class I regulatory classification confirms its status as a regulated medical device. Practitioners must systematically refer to the instructions and warnings provided by the manufacturer to ensure use compliant with safety and clinical efficacy standards.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Hu-Friedy |
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