Orban File #10/11 #2 Handle - Hu-Friedy - Delynov
The Lime Orban #10/11 manche #2 - Hu-Friedy 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 Hu-Friedy Orban #10/11 file handle #2?
The Orban #10/11 file is a high-precision periodontal instrument manufactured by Hu-Friedy Mfg. Co., LLC. This device consists of a specific working part and a #2 type handle, optimized for grip during periodontal care. As a surgical periodontal file, it is designed to operate in restricted spaces where standard curettes may be limited. Its structure allows for an effective scraping action for the treatment of root surfaces. This medical device belongs to Class I according to current regulations, guaranteeing its compliance for professional use in dental practices or hospital settings for oral surgery interventions.
What are the clinical indications for this periodontal instrument?
This manual periodontal file is primarily indicated for the treatment of periodontitis and the cleaning of deep periodontal pockets. It is used by practitioners for the fragmentation of particularly dense or mineralized subgingival calculus that resists conventional scaling instruments. In periodontal surgery, it is used to regularize cementum surfaces and to eliminate granulomatous tissue or residual deposits in difficult-to-access areas, such as root irregularities or interproximal zones. Its use is strictly reserved for qualified healthcare professionals, such as periodontists and dental surgeons, within the framework of periodontal debridement protocols or flap surgeries.
What are the technical characteristics of the Orban #10/11 file?
The Orban #10/11 file is distinguished by its double working configuration, allowing different tooth surfaces to be addressed with a single instrument. The manufacturer Hu-Friedy designed this tool with a number 2 handle, offering a specific balance between weight and diameter for control of the surgical gesture. Unlike a curette, this manual scaling file features multiple cutting edges arranged in series, which allows for a distributed cutting force to break calcified deposits. Its technical design meets the requirements of Class I, ensuring the robustness necessary for the mechanical stresses encountered during intensive root planing in general practice or periodontal specialty.
What are the contraindications to the use of this device?
The use of the Orban #10/11 file is contraindicated for patients with known hypersensitivities to the metallic components of the instrument, although the specific composition is not detailed here. Clinically, its use should be avoided on tooth surfaces presenting severe enamel erosion or unprotected hypersensitive dentin, so as not to aggravate substance loss. Furthermore, this instrument must not be used by unqualified persons, as incorrect angulation or excessive pressure could damage the root cementum or surrounding soft tissues. Systematic reference should be made to the instructions for use and warnings from the manufacturer Hu-Friedy before any intervention.
What are the precautions for use and maintenance for this file?
As a non-resorbable and reusable instrument, the Orban #10/11 file requires a rigorous sterilization protocol between each patient. Professionals must inspect the condition of the cutting edges before use to guarantee the effectiveness of manual scaling and avoid any unnecessary trauma to the periodontal tissues. Particular attention must be paid to cleaning biological debris lodged between the blades of the file. As specified by Hu-Friedy, the instrument is reserved for healthcare professionals and must be handled in accordance with good hygiene and safety practices. Inappropriate sharpening can modify the geometry of the instrument and compromise its clinical performance during surgery.
Who is the manufacturer and what standards are respected by this product?
The Orban #10/11 file is manufactured by Hu-Friedy Mfg. Co., LLC, whose headquarters are located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device is classified as Class I, which implies that it meets the essential safety and performance requirements defined for this category of surgical instruments. As a recognized manufacturer in the field of dental instrumentation, Hu-Friedy ensures traceability and manufacturing quality compliant with professional standards. Practitioners are invited to read the provided instructions for use carefully to ensure compliance with the usage protocols intended by the manufacturer and to maintain the level of safety required during care.
State of the art
Specialized surgical instrumentation is evolving towards ergonomic designs.
Specifications
| Manufacturer | Hu-Friedy |
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