As explained in the Costa Rican Classification and Grouping Guide, there is a comprehensive set of regulations for the categorization and grouping of medical devices (fully explained in Decree 43902-S, specifically in Annex A).
Using this regulatory framework as the legal basis, we will study in this article the classification and grouping of intraoral cameras for Costa Rica. We do provide a brief explanation of the product and how the Ministry of Health considers the classification and grouping (particularly when different models need to be grouped).
General Characteristics of Intraoral Scanners
Referred to as intraoral cameras, these advanced imaging instruments are specifically designed for dental applications. Their primary function is to generate high-resolution images and videos of a patient’s teeth, gums, and other oral structures, enabling dentists to assess areas that may not be readily visible through conventional examination methods.
The visual data obtained from these devices facilitates the identification of cavities, periodontal conditions, and oral lesions. Additionally, the captured imagery serves as a valuable resource for developing individualized treatment strategies that align with each patient’s unique dental needs.
Intraoral scanners are designed to be small, lightweight, and easy to maneuver inside the mouth. They typically consist of a handheld device with a camera at one end, which is often attached to a flexible or articulated hand piece or arm for better access to different areas of the mouth. These cameras are equipped with hi-resolution sensors that capture detailed images or videos of the oral cavity. The images are typically displayed in real-time on a computer monitor or a screen.
Classification According to the Level of Risk
Intraoral scanners fall under Class 2 medical devices, according to Rule 10 from the Costa Rican regulatory framework, as they are active medical devices destined to be used for diagnostic purposes.
Grouping for Sanitary Registration Purposes
When attempting to group different medical devices into one sanitary registry, the following criteria should be considered:
- They must maintain consistency in:
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- Device classification
- Intended use or indication
- Generic denomination
- Registration holder
- Manufacturer
- There may be differences in characteristics between different models if they do not modify the intended use or indication. (i.e., a wireless and a power cord/adapter variation of the same product could be grouped within the same registration).
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- It is of particular interest that intraoral cameras are generally presented in different models, and it is common to group them in the same registration considering the mentioned points.
Conclusion
Intraoral cameras have become a valuable tool in the dentistry industry, enabling dentists to provide better patient care through improved diagnostics, treatment planning and patient education. This guideline intends to serve as a first approach when trying to define and categorize the device.
If you require further assistance in understanding any of the requirements discussed in this article, please contact us at contact@veraqueconsulting.com or check out our guidelines.
