Product Title: Distributor Num D11S Handle Num 30 0.35/23mm - Hu-Friedy - Delynov
The Spreader #D11S manche #30 0,35/23mm - 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 Spreader #D11S #30 handle 0.35/23mm?
The Spreader #D11S is a high-precision manual endodontic instrument manufactured by Hu-Friedy Mfg. Co., LLC. This device consists of a size #30 handle and a tapered shank featuring specific dimensions of 0.35 mm in diameter for a length of 23 mm. Designed to meet the requirements of dental surgery and endodontics, this instrument allows the practitioner to manipulate filling materials with great rigor. Hu-Friedy manufacturing quality guarantees a reliable tool for daily practice interventions. It belongs to the category of manual diagnostic and treatment instruments, offering a response adapted to condensation needs during canal obturation phases.
What are the clinical indications for this instrument?
This instrument is primarily indicated during endodontic obturation phases, specifically for the cold lateral condensation technique of gutta-percha. In oral and endodontic surgery, the Spreader #D11S allows for the creation of space for the insertion of accessory cones, thus ensuring maximum density of the filling within the canal system. Its use is crucial to guarantee the three-dimensional sealing of the canal, thereby preventing periapical reinfections. The 0.35/23mm dimensions make it particularly useful for medium to fine caliber root canals, where precise and controlled penetration is necessary to compact the material against the dentinal walls.
What are the technical characteristics of the Spreader #D11S?
The Spreader #D11S is distinguished by rigorous technical specifications. It has a working part length of 23 mm, allowing it to reach the working length in the majority of root anatomical configurations. Its 0.35 mm diameter at the tip offers sufficient fineness for deep insertion without exerting excessive stress on the root walls. The size #30 handle, developed by Hu-Friedy, is designed to provide a stable grip, facilitating the transmission of lateral condensation force in an axial manner. As a Class I device, this instrument meets the basic safety and performance standards for non-invasive or short-term invasive medical devices used in dental practice.
What are the contraindications for the use of this device?
According to information from the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is reserved exclusively for qualified healthcare professionals. General clinical contraindications include use on roots with suspected or proven longitudinal fractures, where condensation pressure could aggravate structural damage to the tooth. Furthermore, the use of this spreader is contraindicated if the practitioner has not previously established a safe insertion path via adequate canal preparation. It is imperative to read the instructions carefully before use to become aware of all specific warnings provided by the manufacturer regarding patient safety and instrument integrity.
What are the maintenance precautions for this non-resorbable instrument?
The Spreader #D11S is a reusable and non-resorbable metallic instrument. To maintain its performance and longevity, it must be subjected to a rigorous decontamination, cleaning, and sterilization protocol after each use, in accordance with Hu-Friedy instructions. The practitioner must regularly inspect the 0.35/23mm shank to detect any signs of metal fatigue, corrosion, or twisting, as a deformation of the tip could compromise condensation precision or risk intra-canal instrumental fracture. Storage in a dry and clean environment is essential to preserve the technical characteristics of the #30 handle and the active part.
Who is the manufacturer and what standards are respected?
The official manufacturer of this device is Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This product is listed under Class I according to current medical device regulations. As a recognized manufacturer in the global dental sector, Hu-Friedy ensures that its instruments respect the quality and safety requirements necessary for professional clinical use. Although specific CE marking is not mentioned in the source data, compliance with Class I indicates that the product meets regulatory standards for manual dental instruments. Healthcare professionals must systematically refer to the attached instructions for use to ensure use in accordance with the manufacturer's guidelines.
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