Spatula/plugger #6061 handle #6
The Spatule/fouloir #6061 manche #6 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.
| Manufacturer: Hu-Friedy |
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What is the #6061 spatula/plugger with #6 handle?
The #6061 spatula/plugger with #6 handle is a manual instrument designed by the manufacturer Hu-friedy and distributed under the brand Hu-Friedy. This device belongs to the INSTRU category and is distinguished by its double-ended configuration, allowing the practitioner to alternate between the application and condensation of restorative materials. Its structure is designed to provide a stable grip via its number 6 handle, thus facilitating control during the critical stages of dental reconstruction. This product is specifically intended for professional use in dental practices or hospital environments for restorative dentistry procedures.
What are the clinical indications?
This composite modeling instrument is indicated for the placement, packing, and shaping of composite resins or other filling materials. The brand Hu-Friedy offers this tool for direct restoration procedures where modeling precision is fundamental to restoring dental anatomy. It is used during stratification phases to compact material into prepared cavities, ensuring optimal marginal adaptation. Its use is strictly reserved for qualified healthcare professionals, in accordance with the directives of the manufacturer Hu-friedy located in Chicago, USA, to guarantee safe and effective application during clinical care.
What are the technical characteristics?
The #6061 spatula/plugger is characterized by a double working end mounted on a #6 type handle. As a dental spatula plugger, it combines a flat face for spreading and a thicker face for compacting. This device is classified as Class I according to the current regulations for medical devices. The design by the manufacturer Hu-friedy ensures compliance with rigorous manufacturing standards. Although specific material details are not listed, the instrument is designed to withstand standard sterilization cycles in the practice, provided that the instructions in the user manual attached to the Hu-Friedy brand product are followed.
What are the contraindications for use?
According to the data provided by the manufacturer Hu-friedy, there are no specific medical contraindications listed for this instrument, other than its exclusive use by trained healthcare professionals. It is imperative to read the instructions carefully before any use to identify any particular warnings. Like any Class I instrument, its use must be avoided if the device shows signs of degradation or if aseptic conditions are not guaranteed. Clinical application must always be validated by the practitioner based on the patient's health status and the nature of the planned surgical or restorative intervention.
What are the maintenance and durability precautions?
As a non-resorbable and reusable instrument, the #6061 spatula/plugger requires a strict decontamination and sterilization protocol between each patient. Professionals must comply with the warnings from the manufacturer Hu-friedy regarding cleaning. Careful handling is required to preserve the integrity of the working ends of this composite modeling instrument. Any restorative material residue must be removed immediately after the procedure to prevent hardening on the steel, which could compromise precision during subsequent uses. The longevity of this tool from the brand Hu-Friedy depends directly on compliance with the maintenance cycles recommended in the technical manual.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Hu-friedy, located at 3232 N. Rockwell St. Chicago, Il 60618 in the USA. This product is listed under Class I, which corresponds to medical devices presenting a low degree of risk, in accordance with MDR regulations. The brand Hu-Friedy ensures the distribution of this INSTRU category instrument to dental surgeons. Although specific CE marking is not mentioned in the source documentation, the device meets the regulatory requirements imposed on Class I manual instruments. Practitioners are invited to consult the manual for any additional information relating to safety standards and specific use protocols.
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