Modified Sicile periosteal elevator (PPSIC6)
The Periosteal Sicile modifie 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.
What is the modified Periosteal Sicile?
The modified Periosteal Sicile, marketed under the brand Hu-Friedy, is a precision surgical instrument belonging to the category of consumables for oral surgery. This device is specifically designed for demanding practitioners who require a reliable tool for soft tissue work. Its structure is adapted to meet the needs of dental surgeons during the manipulation of the periosteum. As a Class I product, it meets the basic regulatory requirements for non-invasive or invasive medical devices for temporary use. This instrument from the brand Hu-Friedy integrates into the standard surgical site preparation protocol by allowing clear exposure of the underlying bone structures.
What are the clinical indications?
The clinical indications for the modified Periosteal Sicile from the brand Hu-Friedy primarily concern periodontal surgery, implantology, and general oral surgery. Its main use is the detachment of the dental flap, a crucial step to access the alveolar bone. The Sicile elevator is used to gently lift the mucoperiosteum after the incision, thus allowing optimal visibility for implant placement, bone grafting, or the treatment of periodontal defects. This device is strictly reserved for qualified healthcare professionals, ensuring manipulation in accordance with the rules of surgical art. The use of this instrument facilitates soft tissue management throughout the procedure, ensuring clean and precise separation.
What are the technical characteristics?
Technically, the modified Periosteal Sicile is distinguished by its design adapted to restricted clinical environments. Although material specifications are not detailed, this instrument is manufactured by the recognized manufacturer Hu-friedy, based in Chicago, USA. It is classified as a Class I device according to current regulations. The configuration of its ends is optimized for the role of a Sicile elevator, providing an effective interface between the instrument and the periosteal tissue. The brand Hu-Friedy ensures that the ergonomics of the instrument allow for controlled force transmission, thus avoiding accidental tears of the dental flap during its elevation. Its manufacturing meets industrial quality standards for manual surgical instruments.
What are the contraindications for use?
According to the information provided by the manufacturer Hu-friedy, specific contraindications are not listed exhaustively beyond general warnings. However, the use of this instrument is formally reserved for duly trained healthcare professionals. An implicit contraindication lies in use by unqualified personnel or for use other than that intended in oral surgery. As with any Class I surgical instrument, reference should be made to the instructions for use to identify any restrictions related to the patient's clinical condition or hypersensitivities to the instrument components, although not specified here. Compliance with sterilization and maintenance protocols is imperative to avoid any perioperative complications.
What are the precautions for use and maintenance?
As a non-resorbable manual instrument, precautions for use focus on the careful manipulation of tissues to avoid any iatrogenic injury. The practitioner must ensure to inspect the instrument before each use to ensure the absence of deformation or damage to the active parts. The modified Periosteal Sicile must be cleaned, disinfected, and sterilized in accordance with the instructions from the manufacturer Hu-friedy before each intervention. Maintaining the sterility chain is crucial to prevent cross-infections. It is also recommended to follow maintenance guidelines to preserve the cutting or lifting capabilities of the Sicile elevator over the long term, thus ensuring constant performance during the resection of the dental flap.
Who is the manufacturer and what standards are respected?
The modified Periosteal Sicile is manufactured by Hu-friedy, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This manufacturer is globally recognized for the quality of its dental surgery instruments. The product is classified as Class I, which attests to its compliance with safety and performance requirements for this category of medical devices. Although specific CE marking is not mentioned in the source data, Hu-friedy's compliance with American and international manufacturing standards ensures a high level of reliability for healthcare professionals. It is imperative to read the instructions provided by the manufacturer carefully before any use to ensure use in accordance with regulatory and clinical directives.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Hu-Friedy |
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