Sinus Curette #1, Black Line
The Curette Sinus #1, Black Line 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 Sinus Curette #1, Black Line?
The Sinus Curette #1, Black Line is a high-precision surgical instrument manufactured by Hu-Friedy Mfg. Co., LLC. This device belongs to the category of sinus instrumentation, specifically designed for complex oral surgery procedures. It is distinguished by its Black Line finish, a dark coating that reduces reflections under operating lights, thereby facilitating the practitioner's work. As a Class I device, it meets the regulatory requirements for reusable non-invasive or short-term invasive instruments. Its structure is optimized to offer a stable grip and fine tactile response when accessing the internal wall of the maxillary sinus.
What are the clinical indications?
This sinus elevator curette is indicated for pre-implant surgery procedures, more specifically for lateral window sinus elevation. It is used to carefully detach the sinus membrane (Schneiderian membrane) from the bony wall without causing perforation. Its use is reserved for qualified healthcare professionals, such as dentists, implantologists, or stomatologists. The instrument allows for the creation of the space necessary for the insertion of bone grafting materials within the framework of implant rehabilitation where the sub-sinus bone volume is insufficient.
What are the technical characteristics?
The Sinus Curette #1 from Hu-Friedy features a geometry adapted to the anatomical curves of the sinus cavity. Its Black Line design is not only aesthetic; it aims to improve visual contrast between the instrument and the surrounding tissues. Manufactured by Hu-Friedy Mfg. Co., LLC in Chicago, this instrumentation benefits from the manufacturer's metallurgical expertise to guarantee longevity and resistance to repeated sterilization cycles. The thinness of its active ends allows for precise insertion into the bone window, ensuring optimal control during the critical phase of membrane detachment.
What are the contraindications for use?
In accordance with the information provided by the manufacturer Hu-Friedy, specific contraindications are not exhaustively listed in the short technical documentation, beyond the use reserved exclusively for trained healthcare professionals. Generally, the use of this instrument is contraindicated in patients with untreated acute sinus pathologies, active local infections, or any systemic medical condition preventing oral surgery. The practitioner must refer to the instructions for use and evaluate the benefit/risk ratio for each patient before any intervention.
What are the maintenance and handling precautions?
As a Class I non-resorbable instrument, the Sinus Curette #1 requires a rigorous cleaning, disinfection, and sterilization protocol after each use. It is imperative to read the instructions carefully before use to comply with the sterilization parameters recommended by Hu-Friedy. A visual inspection before each procedure is recommended to check the integrity of the instrument and its Black Line coating. Inappropriate handling or excessive pressure could damage the instrument or compromise patient safety during membrane detachment.
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 classified as a Class I medical device according to current regulations. Although specific CE marking is not detailed in the source data, the manufacturer complies with international quality standards for the production of surgical instruments. As a device reserved for healthcare professionals, it must be used in accordance with the manufacturer's directives and current clinical best practices in the field of implantology and oral surgery.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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