Tunneling Knife 1 - Black Series - Hu-Friedy - Delynov
The Couteau de tunnelisation #1 Black Line- Hu-Friedy is a medical device manufactured by Hu-Friedy Mfg. Co., LLC.
- Compliance: Medical device Class I.
- Manufacturer: Hu-Friedy Mfg. Co., LLC.
- Reference: TKN1X.
- Reserved for healthcare professionals. Read instructions carefully before use.
| Manufacturer: Hu-Friedy |
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What is the #1 Black Line Tunneling Knife (TKN1X)?
The #1 Black Line Tunneling Knife, referenced under code TKN1X, is a high-precision instrument manufactured by Hu-Friedy Mfg. Co., LLC. This device belongs to the Black Line range, recognized for its specific finishes intended to optimize visibility during surgical interventions. As a Class I consumable, this instrument is designed to meet the requirements of practitioners performing microsurgery interventions. Its structure is optimized for handling delicate tissues with great rigor, thus facilitating complex technical maneuvers in the oral environment.
What are the clinical indications for this Hu-Friedy instrument?
This instrument is primarily indicated for periodontal plastic surgery procedures, notably the tunnel technique. It is used by dental surgeons and implantologists for the management of gingival recessions and the positioning of connective tissue grafts. The tunneling knife allows for the elevation of the mucogingival complex while preserving the integrity of the interdental papillae. Its use also extends to peri-implant surgery when soft tissue augmentation is required around abutments, ensuring rigorous site preparation for autogenous grafts or tissue substitutes.
What are the technical characteristics of the TKN1X model?
The Hu-Friedy TKN1X knife is distinguished by its ergonomic design adapted to microsurgery. Although exact dimensions are not specified, its morphology is designed to access narrow and difficult-to-reach areas without compromising the stability of the gesture. The Black Line series incorporates a dark coating that reduces light reflections under operatory lighting or when using binocular loupes, thereby improving contrast with soft tissues and blood. This device is categorized as a Class I instrument, in accordance with current regulations for non-invasive or temporary-use invasive medical devices.
What are the contraindications for the use of this microsurgery knife?
Contraindications for the use of the TKN1X tunneling knife are related to oral surgery clinical protocols. Its use is discouraged in patients presenting general contraindications to periodontal surgery, such as uncontrolled coagulation disorders or serious systemic pathologies interfering with healing. It must not be used on tissues presenting untreated acute inflammation or purulent infection. The manufacturer Hu-Friedy specifies that the use of this instrument is strictly reserved for qualified healthcare professionals who have received adequate training for these specific techniques.
What are the maintenance and durability precautions for this instrument?
As a Class I instrument manufactured by Hu-Friedy, maintaining its performance depends on a rigorous sterilization and cleaning protocol. It is imperative to read the instructions carefully before any use to comply with the decontamination cycles recommended by the manufacturer. To preserve the integrity of the cutting edge and the Black Line coating, corrosive chemical products and mechanical shocks between instruments during reprocessing should be avoided. A visual inspection before each intervention is recommended to ensure the absence of deformation or premature wear, thus guaranteeing patient safety and cutting efficiency.
Who is the manufacturer and what standards are met by the TKN1X?
The device is manufactured by 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 regulatory standards. Although specific CE marking is not mentioned in the source data, the manufacturer complies with manufacturing requirements for instruments intended for healthcare professionals. Each TKN1X tunneling knife is subjected to strict quality controls to ensure its compliance with international dental surgery standards. Practitioners must systematically refer to the instructions provided by Hu-Friedy to ensure use in accordance with safety standards.
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