Dental Grinding Bur x2 Strawberry 5 mm - Meisinger - Hager & Meisinger GmbH (39TC21X205050) - Delynov
The x2 fraises 5 mm - Meisinger - Hager & Meisinger GmbH is a medical device manufactured by Hager & Meisinger GmbH — Class IIa, CE marking CE0044.
- Compliance: Medical device Class IIa, CE marking CE0044.
- Manufacturer: Hager & Meisinger GmbH.
- Reference: 39TC21X205050.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Meisinger 5mm surgical bur?
The 5mm surgical bur developed by Meisinger is a high-performance rotary instrument intended for invasive interventions. Identified under technical reference 39TC21X205050, it is specifically sized for bone work requiring a 5 mm cutting diameter. This device is designed to meet the requirements of oral and maxillofacial surgery, offering a structure adapted to cutting hard tissues. As an essential component of rotary instrumentation, this tungsten carbide bur ensures an efficient cutting action while maintaining the stability necessary during critical phases of osteotomy or bone remodeling.
What are the clinical indications for this device?
The indications for use for Meisinger instruments cover a wide spectrum of specialized surgery. This device is indicated for dentistry, implantology, general bone treatment, as well as maxillary surgery and general surgery. It is particularly requested during preoperative planning and the execution of complex surgical techniques where bone reduction or shaping is required. The use of this dental surgery bur is strictly reserved for practitioners with solid training and experience in these disciplines, with the physician deciding under their sole responsibility on its application according to the patient's specific clinical situation.
What are the technical characteristics of reference 39TC21X205050?
Reference 39TC21X205050 corresponds to a pack of two 5 mm burs manufactured by Hager & Meisinger GmbH. Although the exact composition is not specified in the raw MDR data, common surgical use for this type of instrumentation points toward a tungsten carbide bur, recognized for its hardness and cutting capacity on mineralized tissues. The 5 mm diameter is a critical specification for the calibration of osteotomies. Each device is developed for a specific use to avoid premature wear. Compliance with the speed and pressure parameters recommended by the manufacturer in its technical catalog is essential to guarantee the integrity of the instrument during the operative act.
What are the contraindications for the use of these burs?
The manufacturer Hager & Meisinger GmbH specifies that non-compliant use of these devices constitutes a major contraindication, as it can lead to premature wear and involve risks for patients and users. Use is prohibited for any personnel who do not have the required knowledge or adequate experience in dental implantology or maxillary surgery. Although the MDR text does not list specific systemic contraindications, it emphasizes that the choice to use the instrument rests on the diagnosis and decision of the physician on a case-by-case basis. Any serious incident related to the device must be immediately notified to the manufacturer and the competent authorities.
What are the precautions for use and maintenance?
The use of these surgical devices assumes in-depth expertise in diagnosis and surgical techniques. To prevent risks, it is imperative to refer to the manufacturer's specifications available in the official catalog to know the possible applications and technical limits. Non-compliant use can alter the performance of the bur and compromise the safety of the intervention. Meisinger regularly offers continuing education sessions to perfect the mastery of its devices. Practitioners must ensure that the instrument is used within its specific field of application for which it was developed, thus guaranteeing the safety of the user and the patient throughout the care process.
Who is the manufacturer and what standards are respected?
These burs are manufactured by Hager & Meisinger GmbH, a company based in Neuss, Germany. The product belongs to the category of medical consumables and is classified as a Class IIa medical device. It bears the CE0044 marking, certifying its compliance with the European regulatory requirements in force for medical devices. Traceability and safety are at the heart of Meisinger's manufacturing processes, ensuring that each bur meets the high standards required for invasive surgery. Additional information on standards and training related to these devices is accessible on the manufacturer's official website.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Meisinger |
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