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.
What is the #1 Black Line (TKN1X) tunneling knife?
The #1 Black Line tunneling knife, referenced under code TKN1X, is a specialized instrument manufactured by Hu-Friedy. It belongs to the Black Line range, recognized for its dark coating that reduces reflections under operatory lighting while improving contrast with gingival tissues and blood. This periodontal plastic surgery knife is designed with a rigid structure and sharpened ends to allow delicate yet firm soft tissue manipulation during site preparation in periodontology.
What are the clinical indications for this instrument?
This periodontal microsurgery instrument is primarily indicated for performing tunneling techniques. It is used by dental surgeons and periodontists for the elevation of full-thickness or partial-thickness flaps without vertical releasing incisions. Its use is common in periodontal plastic surgery procedures aimed at covering gingival recessions, particularly for preparing the space necessary for the placement of a connective tissue graft or acellular dermal matrices.
What are the technical characteristics of the TKN1X knife?
The Hu-Friedy TKN1X tunneling knife is distinguished by its ergonomic design and Black Line finish. Although exact dimensions are not specified, its shape is optimized to access difficult-to-reach interproximal and sub-gingival areas. As a Class I medical device, it meets the manufacturing requirements of Hu-Friedy Mfg. Co., LLC. Its active tip is specifically profiled to ensure controlled tissue dissection, thereby limiting the risk of flap perforation during tunnel creation.
What are the contraindications for the use of this device?
According to information from the manufacturer Hu-Friedy, specific contraindications are not exhaustively listed in the provided documentation. However, the use of this micro-surgery knife is strictly reserved for qualified healthcare professionals. A general contraindication includes any clinical situation where periodontal surgery is proscribed, such as uncontrolled coagulation disorders or insufficient oral hygiene compromising healing. It is imperative to refer to the instructions for use before any intervention.
What are the maintenance precautions for this non-resorbable instrument?
As a reusable surgical instrument and not a resorbable consumable, the TKN1X knife requires a rigorous sterilization protocol. After each use in periodontal plastic surgery, the instrument must be cleaned, decontaminated, and sterilized according to the Hu-Friedy manufacturer's instructions. Particular attention must be paid to protecting the sharp ends to maintain their cutting efficiency. The practitioner must visually inspect the instrument before each use to detect any signs of wear or degradation of the Black Line coating.
Who is the manufacturer and what standards are met?
The tunneling knife is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, USA. This medical device is listed as Class I according to current regulations. As a Hu-Friedy product distributed by Delynov, it benefits from the expertise of a manufacturer recognized worldwide for the quality of its dental instruments. Compliance with Class I manufacturing standards ensures that the instrument meets essential safety and performance requirements for professional use in a surgical environment.
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Specifications
| Manufacturer | Hu-Friedy |
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