Osteotome Kit for Implantology, Oral Surgery, and Maxillofacial Surgery - Delynov
The Kit Ostéotomes - 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 Osteotome Kit - Hu-Friedy - Delynov?
The Osteotome Kit - Hu-Friedy - Delynov is a set of high-quality surgical instruments designed specifically for bone surgery procedures in implantology. Manufactured by Hu-Friedy Mfg. Co., LLC, this kit includes several osteotomes intended for the manipulation of maxillary and mandibular bone structures. As a Class I medical device, it meets the regulatory requirements for use in a clinical setting. This set is configured to provide practitioners with the necessary tools to perform precise osteotomies, thereby promoting optimal site preparation before implant placement. Hu-Friedy's rigorous design ensures reliable handling during critical phases of oral surgery.
What are the clinical indications for this osteotomy kit?
The Hu-Friedy implant osteotomy kit is indicated for various oral and implant surgery procedures. Its primary use involves bone expansion and condensation of cancellous bone to improve primary implant stability. It is particularly used during crestal sinus lift techniques (Summers technique), where osteotomes allow for the progressive displacement of the sinus floor. This dental bone surgery kit is also employed to prepare implant sites in low-density bone, allowing for the compaction of bone trabeculae rather than removing them by drilling, thus optimizing implant anchorage in posterior maxillary areas.
What are the technical characteristics of this instrument set?
This bone expansion kit consists of manual instruments developed by Hu-Friedy, recognized for their manufacturing quality. Each osteotome is designed to effectively transmit the necessary impaction force during condensation or expansion maneuvers. Although composition specifications are not detailed in the source data, these Class I instruments are intended for strict professional use. The kit configuration provides different diameters and tip shapes (concave or convex) to adapt to the morphology of the surgical site. Maintenance and cleaning of these instruments must follow standard hospital sterilization protocols to ensure patient safety.
What are the contraindications for the use of these osteotomes?
According to information from the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this kit is strictly reserved for qualified healthcare professionals. Contraindications include all clinical situations where bone surgery is prohibited, such as uncontrolled systemic pathologies affecting bone healing or active local infections at the surgical site. It is imperative to refer to the instructions for use provided by the manufacturer to identify specific warnings related to the patient's health status. A rigorous preoperative assessment is necessary to ensure that bone density and volume are compatible with the use of manual expansion or condensation instruments.
What are the precautions for use and maintenance for these instruments?
As Class I non-resorbable instruments, the Hu-Friedy Osteotome Kit requires careful handling to maintain the integrity of the working parts. Before each procedure, the practitioner must inspect the instruments for any signs of wear or deformation. Cleaning, disinfection, and sterilization must be carried out in accordance with the manufacturer's instructions: Hu-friedy 3232 N. Rockwell St. Chicago, Il 60618 USA. It is essential to read the instructions carefully before use. Compliance with reprocessing protocols is crucial to prevent cross-contamination risks and ensure the longevity of the instruments within the dental office or surgical clinic.
Who is the manufacturer and what standards are met by this kit?
The Osteotome Kit is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This manufacturer is globally recognized for its expertise in producing precision surgical instruments. The product is classified as a Class I medical device. Compliance with this regulatory class ensures that the instrument meets the safety and performance standards defined for non-invasive or temporary-use invasive medical devices. The CE marking is not specified in the current source documentation, but compliance with Hu-Friedy manufacturing standards ensures consistent quality for implantology and bone surgery procedures.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
| Manufacturer | Hu-Friedy |
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