Bone-Shaver Osteotome #1.42 Straight Concave 4.2mm - Hu-Friedy - Delynov
The Ostéotom Bone-Shaver #1.42 concave droit 4.2mm - 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 Bone-Shaver #1.42 straight concave 4.2mm Osteotome - Hu-Friedy?
The Bone-Shaver #1.42 Osteotome is a precision surgical instrument manufactured by Hu-Friedy Mfg. Co., LLC. This device is characterized by a concave-shaped working end and a straight shaft, with a specific dimension of 4.2mm. It belongs to the consumables (CONSO) category and is classified as a Class I medical device. Its structure is optimized to meet the requirements of dental surgeons and implantologists during bone preparation phases. As a Hu-Friedy product, it benefits from the expertise of a manufacturer recognized in the field of dental instrumentation, guaranteeing a tool adapted to rigorous clinical protocols.
What are the clinical indications for this osteotome?
This straight concave osteotome is primarily indicated for oral and implant surgery procedures. Its intended use includes the preparation of implant sites, particularly for bone condensation or ridge expansion. The concave shape of the 4.2mm tip is particularly useful for collecting or moving autogenous bone while creating a precise implant socket. It is also used in crestal sinus lift procedures where a straight approach is preferred by the practitioner. This device is strictly reserved for healthcare professionals trained in these specific surgical techniques.
What are the technical characteristics of this instrument?
The main technical characteristics of this instrument are based on its geometry and dimensions. It is a Bone-Shaver #1.42 model featuring a 4.2mm active part. Its configuration is of the straight concave type, allowing for direct and axial action on the bone tissue. Manufactured by Hu-Friedy, this instrument complies with the quality standards associated with Class I devices. The straight design facilitates the transmission of force during manual or mallet impaction, while the concavity of the tip ensures better stability on the bone ridge or during the displacement of bone chips during surgery.
What are the contraindications for the use of this osteotome?
According to the information provided by the manufacturer Hu-Friedy Mfg. Co., LLC, the use of this instrument is reserved exclusively for qualified healthcare professionals. General contraindications include any clinical situation where bone density is insufficient to support manual instrumentation or when the patient's general health status contraindicates invasive oral surgery. Although the raw MDR text does not list specific medical contraindications related to materials, it is imperative to refer to the instructions for use and evaluate the risks of potential allergies before any intervention.
What are the precautions for use and maintenance?
As a Class I instrument that is non-sterile upon delivery, it is essential to read the manufacturer's instructions carefully before the first use. The practitioner must ensure compliance with the cleaning, disinfection, and sterilization protocols recommended by Hu-Friedy to guarantee patient safety and the longevity of the instrument. Precautions must be taken during handling to avoid damaging the 4.2mm concave tip. A visual examination before each procedure is recommended to ensure the absence of deformation or corrosion. The instrument must be used in accordance with its intended use in bone surgery.
Who is the manufacturer and what standards are respected?
The Bone-Shaver #1.42 Osteotome is manufactured by Hu-Friedy Mfg. Co., LLC, located at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device complies with the current regulations for Class I instruments. Hu-Friedy is a globally recognized manufacturer for the quality of its surgical instruments. Compliance with the indications and warnings mentioned by the manufacturer is essential for safe practice. Healthcare professionals must consult the technical documentation and the instructions for use accompanying the product to ensure the compliance of the procedures implemented.
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| Manufacturer | Hu-Friedy |
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