Romerowski root elevator handle Number 41 - Hu-Friedy - Delynov
The Brunissoir Romerowski manche #41 - 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 Romerowski burnisher handle #41 - Hu-Friedy?
The Romerowski burnisher with handle #41 is a precision manual instrument manufactured by Hu-Friedy Mfg. Co., LLC. This device belongs to the category of restorative instruments (INSTRU) and consists of a working part specific to the Romerowski model mounted on an ergonomic handle type #41. As a Class I instrument, it is designed to meet the requirements of practitioners in oral surgery and restorative dentistry. Hu-Friedy's manufacturing quality ensures a robust structure adapted to the mechanical stresses encountered during the manipulation of filling materials. Its design allows for a stable grip for optimal control of the clinical movement during the finishing phases of cavities.
What are the clinical indications for this instrument?
This instrument is primarily indicated for working with dental restorative materials. In clinical practice, the Romerowski burnisher is used for smoothing amalgam or composite surfaces, as well as for perfecting the adaptation of the restoration edges with the tooth walls. It is used after the material is inserted into the cavity to ensure condensation and to sculpt the anatomical reliefs necessary for proper occlusion. Its use is common in conservative dentistry procedures where the precision of the tooth-material interface is crucial for the longevity of the treatment. It also allows for the removal of excess material around the periphery of the preparation before polymerization or final setting.
What are the technical characteristics of this Hu-Friedy device?
The Romerowski burnisher is distinguished by its handle #41, a specific reference from Hu-Friedy offering a balance between weight and diameter to limit muscle fatigue during prolonged use. Although detailed material specifications are not provided, instruments in this range are developed by Hu-Friedy Mfg. Co., LLC to withstand repeated sterilization cycles in the dental office. It is a non-sharp instrument whose tip geometry is specifically designed for burnishing, which is the action of polishing by friction and controlled pressure. This device is classified as a Class I medical device, guaranteeing its compliance with safety standards for non-invasive instruments used by healthcare professionals.
What are the contraindications for the use of this burnisher?
According to information from the manufacturer Hu-Friedy, the use of this instrument is strictly reserved for qualified healthcare professionals. There are no specific medical contraindications listed in the raw technical documentation, other than the usual precautions related to the condition of the instrument. The practitioner must ensure the integrity of the working part before any intervention. Misuse of the instrument for prying tasks or on unintended structures (such as bone or massive metal prostheses) could damage the device or compromise patient safety. It is imperative to refer to the instructions for use provided by Hu-Friedy before the first use to identify any specific restrictions.
What are the maintenance and handling precautions?
Like any Class I instrument intended for oral surgery and dental care, the Romerowski burnisher requires a rigorous decontamination and sterilization protocol between each patient. Although it is not a resorbable device, its durability depends on compliance with the cleaning instructions recommended by Hu-Friedy Mfg. Co., LLC. Appropriate cleaning solutions should be used to avoid corrosion or degradation of the handle #41. Storage should be in a dry and clean environment. Regular visual inspection is recommended to detect any wear of the burnishing tip, which could alter the quality of the smoothing of restorative materials and potentially create undesirable micro-roughness on the treated surfaces.
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 globally recognized player in the manufacture of high-quality dental instrumentation. This Romerowski burnisher complies with medical device regulations by being listed as a Class I product. This classification implies that the device meets the essential safety and performance requirements defined for reusable manual instruments. Healthcare professionals are invited to read the instructions carefully before use to ensure use in accordance with the manufacturer's guidelines and to ensure the safety of the care provided in dental offices or hospital settings.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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