Bone-Spreader Osteotome #1 convex max 2.7mm - Hu-Friedy - Delynov
The Ostéome Bone-Spreader #1 convexe maxi 2.7mm - 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 Bone-Spreader #1 convex maxi 2.7mm osteotome?
The Bone-Spreader #1 osteotome designed by Hu-Friedy is a manual surgical instrument used primarily in oral implantology. This device is characterized by a convex-shaped tip with a maximum diameter of 2.7mm. Unlike rotary drills that remove bone substance, this instrument is designed to compact and widen the walls of the socket through manual pressure. Manufactured by Hu-Friedy Mfg. Co., LLC, this tool meets the quality requirements of practitioners performing ridge preparation surgeries. It is part of a tissue preservation approach by exploiting the viscoelasticity of the bone to create an adequate implant housing while locally increasing bone density.
What are the clinical indications for this instrument?
The purchase of a bone spreader type osteotome is indicated for ridge expansion and bone condensation procedures. In implant surgery, it is used to progressively widen narrow implant sites or to compact low-density bone (Types III and IV). Using the bone spreader 2 7mm improves the primary stability of the implant by reinforcing the surrounding bone walls. It is also employed during crestal sinus lift techniques to condense the filling material under the sinus membrane. This instrument is exclusively reserved for use by health professionals qualified in oral surgery and implantology, ensuring precise handling during the critical phases of site preparation.
What are the technical characteristics of this device?
This implant bone spreader features a convex working part with a peak diameter of 2.7mm. This specific geometry is designed to distribute forces evenly over the bone walls, thus avoiding unwanted cortical fractures while maximizing expansion. The design of the instrument allows for direct transmission of the force applied by the practitioner, providing essential tactile feedback to assess bone resistance. As a Class I device, it complies with regulatory standards for non-invasive or invasive surgical instruments for temporary use. The design by the manufacturer Hu-Friedy ensures mechanical resistance adapted to the pressure constraints encountered during alveolar ridge expansion.
What are the contraindications for the use of this osteotome?
Contraindications related to the use of the Hu-Friedy Bone-Spreader #1 osteotome include clinical situations where bone density is excessively high (Type I bone), as the risk of fracture or thermal necrosis by compression is increased. Its use is prohibited in patients with serious systemic pathologies affecting bone healing or calcium metabolism without prior medical advice. It must not be used if the residual ridge width is insufficient to support expansion without risk of dehiscence. As indicated by the manufacturer Hu-Friedy Mfg. Co., LLC, use is strictly reserved for trained health professionals. Failure to comply with sterilization protocols or use on bone presenting an active infection also constitutes a major contraindication.
What are the precautions for use and maintenance?
As a non-resorbable and reusable instrument, this implant osteotome requires rigorous decontamination and sterilization before each intervention, in accordance with the instructions for use provided by Hu-Friedy. The practitioner must inspect the 2.7mm convex tip before use to ensure the absence of deformation or corrosion. During expansion, progression must be slow and sequenced to allow for plastic deformation of the bone without rupture. It is recommended to use instruments of increasing diameters to reach the desired final dimension. Excessive pressure or an inappropriate insertion angle can compromise the integrity of the bone plate. After use, manual or ultrasonic cleaning followed by autoclaving is imperative to maintain the performance of the device.
Who is the manufacturer and what standards are respected?
The Bone-Spreader #1 osteotome is manufactured by Hu-Friedy Mfg. Co., LLC, headquartered at 3232 N. Rockwell St. Chicago, Il 60618 USA. This medical device belongs to Class I according to current regulations. As a recognized manufacturer in the dental sector, Hu-Friedy guarantees that this instrument is designed to meet the clinical requirements of healthcare professionals. Although specific CE marking is not detailed in the source data, the product follows the brand's rigorous manufacturing protocols. Users are invited to carefully read the manufacturer's instructions and warnings before any handling. Traceability and compliance with manufacturing standards for Class I medical devices ensure the safety and reliability of the instrument during surgical procedures.
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| Manufacturer | Hu-Friedy |
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