Applicator handle number 6 calcium hydroxide - Hu-Friedy - Delynov
The Applicateur manche #6 hydroxyde Calcium - 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 #6 handle calcium hydroxide applicator?
The #6 handle applicator from the brand Hu-Friedy is a manual instrument specifically designed for restorative care procedures. Manufactured by Hu-Friedy Mfg. Co., LLC, this device belongs to the category of placement instruments for cavity liner materials. Its structure includes an ergonomic #6 size handle, offering a stable grip for the practitioner, and a working end adapted to the viscosity of calcium hydroxide. As a calcium hydroxide placement instrument, it allows for the precise transfer of material from the mixing pad to the prepared cavity, ensuring localized application without contamination of the surrounding walls.
What are the clinical indications for this instrument?
This dental calcium hydroxide applicator is indicated during direct or indirect pulp capping protocols. In dental surgery, it is used to deposit a thin protective layer on deep dentin to stimulate the formation of tertiary dentin or to protect the pulp from chemical and thermal aggressions of restorative materials. This cavity liner placement instrument is also useful for the application of dycal-type cements. Its use is strictly reserved for qualified healthcare professionals involved in conservative dentistry or endodontics, in accordance with current clinical protocols for the protection of the dentin-pulp complex.
What are the technical characteristics of the Hu-Friedy applicator?
The instrument is distinguished by its #6 handle, a Hu-Friedy reference for balance and comfort of use. Although detailed material specifications are not listed, the manufacturing standards of Hu-Friedy Mfg. Co., LLC ensure the necessary resistance to standard sterilization cycles in the practice. This dental dycal applicator has a fine tip allowing it to reach the bottom of narrow cavities or difficult-to-access areas. Its design aims to minimize material adhesion to the instrument, thus facilitating a clean release onto the targeted dental surface. It is a robust device designed for repeated use after decontamination.
What are the contraindications for the use of this device?
According to the data provided by the manufacturer Hu-Friedy, no specific medical contraindications are listed in the raw technical documentation. However, the use of this instrument is contraindicated for any application other than that intended by the manufacturer, namely the placement of cavity liner materials. Like any reusable metallic instrument, it must not be used if the practitioner notices visible surface degradation or a bending of the working end that could compromise the precision of the gesture or patient safety. Reference should systematically be made to the instructions for use provided by the manufacturer for safety updates.
What are the maintenance and sterilization precautions?
As the #6 handle applicator is a Class I device non-sterile at purchase, it must imperatively undergo a complete cleaning, disinfection, and sterilization protocol before its first use and between each patient. The practitioner must carefully read the instructions to respect the sterilization parameters recommended by Hu-Friedy. It is essential to remove any calcium hydroxide or cement residue immediately after the clinical act, as the hardening of these materials on the tip of the instrument can alter its future performance. Regular inspection of the handle and tip condition is recommended to maintain an optimal level of care.
Who is the manufacturer and what standards are respected?
The applicator is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is classified as Class I according to current regulations. The manufacturer is internationally recognized for the quality of its dental instrumentation. Although specific CE marking is not mentioned in the source data, the product meets the regulatory requirements applicable to medical devices of its class. As a Class I device, it is subject to rigorous quality controls to guarantee its compliance with the described clinical uses. Healthcare professionals must refer to the manufacturer's instructions to ensure compliant use.
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Specifications
| Manufacturer | Hu-Friedy |
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