{"id":3180,"date":"2025-05-20T20:45:05","date_gmt":"2025-05-20T20:45:05","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3180"},"modified":"2025-06-30T20:04:51","modified_gmt":"2025-06-30T20:04:51","slug":"classification-and-grouping-of-intraoral-scanners-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/classification-and-grouping-of-intraoral-scanners-in-costa-rica\/","title":{"rendered":"Classification and Grouping of Intraoral Scanners in Costa Rica"},"content":{"rendered":"

As explained in the Costa Rican\u00a0<\/span>Classification and Grouping Guide<\/span><\/a>, there is a comprehensive set of regulations for the categorization and grouping of medical devices (fully explained in Decree 43902-S, specifically in\u00a0Annex A).\u00a0<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span><\/p>\n

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).<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

General Characteristics of Intraoral Scanners<\/span><\/b>\u00a0<\/span><\/h3>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

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.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

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\u2019s unique dental needs.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

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.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

Classification According to the Level of Risk<\/span><\/span><\/span><\/b><\/h3>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

Intraoral scanners fall under\u00a0<\/span>Class 2 medical devices<\/span><\/b>, according to the Costa Rican regulatory framework, as they are <\/span>active medical devices<\/span><\/b>\u00a0destined to be used for diagnostic purposes.<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

Grouping for Sanitary Registration Purposes<\/span><\/b>\u00a0<\/span><\/h3>\n

\u00a0<\/span>\u00a0<\/span><\/h3>\n

When attempting to group different medical devices into one sanitary registry,\u00a0the following criteria should be considered:<\/span>\u00a0<\/span><\/p>\n

\u00a0<\/span>\u00a0<\/span><\/p>\n

    \n
  1. They must maintain consistency in:<\/span>\u00a0<\/span><\/li>\n<\/ol>\n
      \n
    1. \n
        \n
      1. Device classification<\/span>\u00a0<\/span><\/li>\n
      2. Intended use or indication<\/span>\u00a0<\/span><\/li>\n
      3. Generic denomination<\/span>\u00a0<\/span><\/li>\n
      4. Registration holder<\/span>\u00a0<\/span><\/li>\n
      5. Manufacturer<\/span><\/li>\n<\/ol>\n<\/li>\n
      6. 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).\u00a0<\/span><\/li>\n
      7. \n
          \n
        1. 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.<\/span>\u00a0<\/span><\/li>\n<\/ol>\n<\/li>\n<\/ol>\n

          \u00a0<\/span>\u00a0<\/span><\/p>\n

          Conclusion<\/span><\/b>\u00a0<\/span><\/h3>\n

          \u00a0<\/span>\u00a0<\/span><\/p>\n

          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.<\/span>\u00a0<\/span><\/p>\n

          \u00a0<\/span>\u00a0<\/span><\/p>\n

          If you require further assistance in understanding any of the requirements discussed in this article, please contact us at\u00a0<\/span>contact@veraqueconsulting.com<\/span><\/a>\u00a0or check out our\u00a0<\/span>guidelines<\/span><\/a>.<\/span>\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

          As explained in the Costa Rican\u00a0Classification 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\u00a0Annex A).\u00a0\u00a0 \u00a0 Using this regulatory framework as the legal basis, we will study in this article the classification and grouping of intraoral cameras for […]<\/p>\n","protected":false},"author":6,"featured_media":3181,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,386],"tags":[],"class_list":["post-3180","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-costa-rica"],"yoast_head":"\nClassification and Grouping of Intraoral Scanners in Costa Rica - Veraque Costa Rica<\/title>\n<meta name=\"description\" content=\"Learn about the classification of intraoral scanners in Costa Rica. 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