x5 Special Diamond-coated Fraise 839R - Meisinger - Hager & Meisinger GmbH (510839R314012) - Delynov
The x5 fraises diamantées spéciales 839R FG(turbine)- 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: 510839R314012.
- Reserved for healthcare professionals. Read instructions carefully before use.
What is the Meisinger 839R FG turbine bur?
The Meisinger 839R FG turbine bur is a high-precision rotary instrument intended for oral and dental surgery. This device, identified under the technical reference 510839R314012, is a diamond dental bur designed to be mounted on a contra-angle or a high-speed turbine (Friction Grip). Manufactured by Hager & Meisinger GmbH, it consists of a standardized shank and a working part coated with diamond grains, offering a cutting capacity adapted to mineralized tissues. This pack of 5 units allows practitioners to have an operational stock for interventions requiring high-performance rotary instrumentation in a surgical environment.
What are the clinical indications for this device?
The clinical indications for this FG surgery bur cover a wide spectrum of odontological and surgical practice. According to data from the manufacturer Hager & Meisinger GmbH, use is indicated in dentistry, implantology, bone treatment, as well as in maxillary and general surgery. It is primarily used during procedures requiring the removal of hard tissues or the rectification of bone and dental structures. The choice to use this specific surgical turbine bur rests with the practitioner (dentist or specialized surgeon), who must evaluate the clinical situation on a case-by-case basis according to the diagnosis and established preoperative planning.
What are the technical characteristics of reference 510839R314012?
Reference 510839R314012 corresponds to the Meisinger 839R FG model. It is a diamond bur whose specificity lies in its FG (Friction Grip) type fixation, compatible with turbines and certain surgical contra-angles. The diamond coating ensures effective abrasion while the 839R geometry defines the specific shape of the working part for precise technical movements. This Class IIa medical device meets the rigorous manufacturing requirements of Hager & Meisinger GmbH. Each instrument is developed for a specific application to avoid any premature wear that could result from use not in accordance with the manufacturer's technical recommendations.
What are the contraindications and limits of use?
The use of these surgical devices is strictly reserved for dentists, doctors, and specialists with solid training and experience in their respective disciplines (implantology, maxillary surgery). Use not in accordance with the manufacturer's specifications constitutes a major contraindication, as it can lead to premature wear of the device and present risks to the patient or user. Although the MDR text does not list specific physiological contraindications, the decision to use it rests on the full responsibility of the medical practitioner after analyzing the patient's particular situation and the potential risks associated with the surgical act.
What are the precautions for use and maintenance?
To ensure the safety and efficacy of the Meisinger turbine bur, the practitioner must respect diagnostic and preoperative planning protocols. Inappropriate use can compromise the integrity of the instrument. It is imperative to refer to the manufacturer's catalog and technical specifications for recommended rotation speeds and cleaning/sterilization procedures if applicable. Any serious incident related to the use of this diamond dental bur must be immediately notified to the manufacturer Hager & Meisinger GmbH as well as to the competent authority of the Member State where the user or patient resides.
Who is the manufacturer and what standards are respected?
These burs are manufactured by Hager & Meisinger GmbH, a company based in Neuss, Germany. This medical device is classified as Class IIa in accordance with current medical device regulations. It benefits from the CE0044 marking, guaranteeing its compliance with European safety and performance requirements. The manufacturer regularly offers continuing education sessions to support professionals in the optimal use of their devices. Traceability and manufacturing quality are ensured by compliance with strict international standards applied by Meisinger in its industrial production processes.
State of the art
Surgical medical consumables play a decisive role in operative safety.
Specifications
| Manufacturer | Meisinger |
| Tags | |
|---|---|
| Tags | |