Swiss Perio Periosteal Elevator Black Line
The Swiss Perio Décolleur 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 Swiss Perio Décolleur Black Line?
The Swiss Perio Décolleur Black Line is a high-precision manual instrument developed by Hu-Friedy, a recognized manufacturer in the field of surgical instrumentation. This device belongs to the Black Line range, characterized by a specific dark coating that reduces reflections under operating lights and improves contrast between the instrument and soft or hard tissues. This gingival elevator is structured to meet the requirements of practitioners performing microsurgery interventions where visibility and precision of movement are paramount. As an instrument in the INSTRU category, it benefits from the expertise of Hu-Friedy Mfg. Co., LLC to offer a solution adapted to the needs of clinics specialized in periodontology and implantology.
What are the clinical indications?
This instrument is primarily indicated for oral and periodontal surgery procedures requiring fine tissue manipulation. In clinical practice, the Swiss Perio Décolleur Black Line is used for flap elevation, allowing exposure of the alveolar bone or site preparation for implant placement. Its use is particularly relevant in microsurgery, where the practitioner must navigate narrow spaces without traumatizing adjacent structures. Indications include the management of full-thickness or partial-thickness flaps, as well as guided tissue regeneration procedures. In accordance with Hu-Friedy manufacturer guidelines, the use of this device is strictly reserved for qualified healthcare professionals mastering oral surgery techniques.
What are the technical characteristics?
The Swiss Perio Décolleur Black Line is distinguished by its ergonomic design and unique black technical finish. This coating is not merely aesthetic; it is designed to minimize the surgeon's eye fatigue by absorbing intense light from the surgical lamp. The geometry of the active tips is optimized to insert under the marginal gingiva and initiate elevation with great fluidity. Manufactured by Hu-Friedy Mfg. Co., LLC in Chicago, this instrument adheres to rigorous manufacturing standards to ensure consistent performance during sterilization cycles and repeated use. Although exact dimensions are not specified here, the Black Line range is renowned for its lightness and balance in the hand, facilitating fine dissection movements.
What are the contraindications for use?
According to information provided by the manufacturer Hu-Friedy, there are no specific medical contraindications listed other than use being reserved for trained healthcare professionals. However, as with any manual surgical instrument, the use of this elevator is contraindicated if the instrument shows signs of wear, corrosion, or structural damage that could compromise patient safety or the effectiveness of the procedure. The practitioner must evaluate the suitability of the tool based on the patient's morphology and the pathology being treated. It is imperative to refer to the instructions for use and follow cleaning and sterilization protocols to avoid any risk of cross-contamination or material failure during the intervention.
What are the maintenance and handling precautions?
As the Swiss Perio Décolleur Black Line is a non-resorbable and reusable instrument, it requires rigorous maintenance. Before the first use and after each intervention, the device must be cleaned, inspected, and sterilized in accordance with Hu-Friedy instructions. It is essential to handle the instrument with care to preserve the integrity of the Black Line coating. The use of inappropriate cleaning solutions or non-validated sterilization methods could alter the surface properties and reduce the instrument's lifespan. Professionals must read the instructions carefully before use to ensure that thermal or chemical treatment cycles are compatible with the Class I specifications of the device.
Who is the manufacturer and what standards are respected?
The Swiss Perio Décolleur Black Line is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is classified as Class I according to current regulations. As a Class I product, it meets the safety and performance requirements applicable to manual surgical instruments. The manufacturer Hu-Friedy is globally recognized for its compliance with quality standards in the production of dental instruments. Adherence to strict manufacturing protocols ensures that dental surgeons and implantologists have a reliable tool that meets regulatory expectations for use in a professional clinical environment. It is reminded that the use of this instrument is strictly reserved for healthcare practitioners.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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