Piezotome Cube + essential kit + complimentary kit - Acteon (F50100) for implantology, oral surgery, dental surgery, oral surgeon, bone grafting, maxillofacial surgery.
The Piézotome Cube + kit essentiel + kit supplementaire au choix offert - Acteon is a medical device manufactured by le fabricant — Class I, CE marking CE0459.
- Compliance: Medical device Class I, CE marking CE0459.
- Manufacturer: le fabricant.
- Reference: F50100.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Piézotome Cube + essential kit - Acteon (F50100)?
The Piézotome Cube, referenced under code F50100, is a piezoelectric surgery device developed by the ACTEON brand. This Class I medical device uses ultrasonic technology to perform precise bone cuts. It is delivered as a kit including the control unit, a high-performance handpiece, as well as an essential kit of tips. An additional kit of choice is also offered in this configuration. This piezo surgery motor is specifically designed to meet the requirements of modern oral surgery, offering an alternative to conventional rotary instruments for the treatment of mineralized tissues.
What are the clinical indications for this piezoelectric surgery device?
The dental surgery piezotome is indicated for a wide range of procedures in oral and implant surgery. Its primary use concerns osteotomy, osteoplasty, and piezocision techniques. It is particularly suitable for delicate interventions such as sinus lifts, ridge expansion, bone graft harvesting, or complex extractions. This device allows for rigorous management of bone structures while respecting the surrounding soft tissues. Use is strictly reserved for graduated and qualified dental health professionals acting within the framework of their usual activities and mastering established scientific data.
What are the technical characteristics of this ultrasonic surgery device?
The Piézotome Cube (F50100) from the ACTEON brand is distinguished by its advanced ultrasonic technology. As a Class I device with CE0459 marking, it integrates strict safety and hygiene protocols. The system is designed to be used regardless of the weight, age, height, or nationality of the adult patient. The control unit manages the power delivered to the handpiece to optimize cutting efficiency on bone. The included essential kit covers fundamental needs in bone surgery, while the free additional kit allows for customization of the equipment according to the practitioner's specialty, whether in periodontology or implantology.
What are the contraindications for the use of the Piézotome Cube?
The use of this medical device involves specific contraindications defined by the manufacturer SATELEC (ACTEON Group). It is formally prohibited to use this device on infants, as well as on pregnant or breastfeeding women, due to restrictions related to the possible use of associated medicinal solutions. Furthermore, patients with serious medical complications, known allergies to the device's components, or possessing a clinical site not suitable for treatment must not be treated with this equipment. The patient must imperatively be calm, immobile, and ideally placed in a lying position to ensure the safety of the intervention.
What are the precautions for use for the practitioner?
The user of the Piézotome Cube must not be the patient and must imperatively wear gloves. The manufacturer specifies that the practitioner must not have any uncorrected visual impairment, nor any infirmity of the upper or lower limbs that would prevent the manipulation of the handpiece or the control pedal. Hearing, memory, or concentration disorders are also limiting factors, as they could hinder the perception of audible indicators or compliance with care protocols. Finally, the user must master medical hygiene principles, including the rigorous cleaning, disinfection, and sterilization of medical devices after each use.
Who is the manufacturer and what standards are met?
The Piézotome Cube is manufactured by SATELEC, an ACTEON Group company, located in Mérignac, France. This medical device complies with current regulations, categorized as Class I and bearing the CE0459 marking. The manufacturer requires compliance with dental practice rules in accordance with scientific data. As a product of the ACTEON brand, it benefits from the expertise of a manufacturer recognized in the field of ultrasonic instrumentation. Traceability and compliance with European safety standards guarantee dental surgeons reliable equipment for their daily interventions in bone and implant surgery.
State of the art
Single-use sterile surgical kits significantly reduce intraoperative contamination.
Specifications
| Manufacturer | Acteon |
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