X1 surgical diamond H95 - JOTA

What is the X1 surgical diamond H95 - JOTA bur?

The X1 surgical diamond H95 bur, referenced under code 4801.H95.018 by the JOTA JOTA, is a rotary instrument intended for bone surgery. This medical device from the CONSO category is distinguished by its specific diamond coating, designed for the abrasion of hard tissues. Its metallic structure is developed to meet the requirements of dental and implant surgery. As a product distributed by Delynov, this h95 diamond bur meets the needs of practitioners seeking a reliable tool for bone work. It is delivered non-sterile and requires a complete cleaning and sterilization protocol before its first use in the office or operating room.

What are the clinical indications?

This dental surgery diamond bur is primarily indicated for osteotomy and osteoplasty procedures. It is used by oral surgery experts for the removal or remodeling of bone structure during pre-implant or periodontal phases. The use of this coarse grit diamond bur allows for effective reduction of bone mass while maintaining precise control of the surgical gesture. According to the recommendations of the manufacturer JOTA AG, the instrument is reusable. However, the physician or expert user remains solely responsible for the decision to reuse the product, scrupulously evaluating the state of wear or the risks of breakage according to each specific clinical case encountered.

What are the technical characteristics?

The JOTA bone surgery diamond bur (4801.H95.018) is a Class IIa rotary instrument. It features a coarse grit diamond working part, optimized for cutting efficiency on hard surfaces. The metallic components of the instrument are compatible with ultrasonic cleaning, provided that non-foaming cleaning agents are used. The manufacturer specifies that material resistance must be verified by referring to specific instructions regarding detergent concentration, temperature, and soaking time. To guarantee performance, it is imperative to use sterile demineralized or low-contamination water during the final rinse to avoid any deposits on the diamond.

What are the contraindications for use?

There are no specific contraindications listed by the manufacturer JOTA AG other than manifest wear of the product. However, the manufacturer emphasizes that optimal operation and performance cannot be guaranteed if the instruments are worn. In case of doubt regarding the integrity of the sterile diamond bur (after processing) or its cutting capacity, it is strongly recommended to discard the product prematurely and replace it with a new instrument. The expert must also ensure the compatibility of the chemical agents used during reprocessing with the metallic materials of the bur to avoid any premature degradation of the diamond binder.

What are the precautions related to reprocessing and wear?

All instruments from the JOTA JOTA are classified as semi-critical and must undergo a complete cycle of cleaning, disinfection, and sterilization before each application. The user is responsible for the sterility of the devices and must implement validated procedures. It is crucial to avoid any contamination by inadequate rinsing solutions; the water used must have a low germ and endotoxin load. The decision to reuse is based on the expert's evaluation: a bur showing signs of breakage or a loss of its abrasive power must be discarded immediately. Using a worn h95 diamond bur could compromise patient safety and the effectiveness of the surgical procedure.

Who is the manufacturer and what standards are met?

The official manufacturer of this device is JOTA AG, located in Rüthi, Switzerland. This product bears the CE0483 marking, certifying its compliance with European regulatory requirements for medical devices. Categorized as Class IIa, this instrument meets strict safety and performance standards. The JOTA JOTA imposes rigorous protocols for the reprocessing of its devices, applicable to its entire range distributed by Delynov. Compliance with the approved parameters for each sterilization cycle, as well as regular maintenance of the equipment (washer-disinfector, sterilizer), are essential to maintain the device's compliance with current public health standards.

State of the art

Surgical medical consumables play a decisive role in operative safety.