In our Classification and Grouping Ultimate Guide, we have explained how to classify and group medical devices in Costa Rica according to the 16 rules detailed in Decree 43902-S by the Ministry of Health. Also, we have explained how to make use of those rules to classify and group specific medical devices such as orthopedic implants, ultrasound systems , in vitro diagnostics, surgical instruments and others.
In this article, we will explain the general characteristics of dental resins and strategies to classify and group this product in Costa Rica.
General characteristics of dental resins
In Costa Rica’s medical device sector, dental resins are used to repair or restore tooth defects and decay. These devices are mostly made of synthetic materials, employed to rehabilitate the damage made by dental cavities, fractures or cracks. Additionally, they help reshape or adjust a tooth’s dimensions to enhance both its functionality and appearance.
Dental resins are usually made of three components: an organic component, an inorganic component and a cohesive agent.
These components may be supplied as:
- Two-part base and catalyst systems, cured by chemical activation, or
- One-part systems, cured by photo initiation, with or without chemical activation.
On the other hand, there are various types of dental resins. For instance:
- Microfilling: used to restore the decay made by dental cavities. Also to correct color or shape in specific locations of the tooth. It is made of particles between 0.01 and 0.05 µm.
- Hybrid: possesses high stress tolerance. Employed mostly on posterior dental restoration and, on occasions, as a dental reconstruction material.
- Nanofilling: made of particles of less than 0.01 µm. Generates a highly aesthetic appearance and its tearing resistance is similar to the hybrid type.
- Modern Hybrid: Owns excellent mechanical capabilities, but complicated to polish and loses its luster rapidly once placed.
- Macrofilling: also known as traditional resins. Made of particles between 10 and 50 µm. Considered as a poorly clinical efficient type that creates poor aesthetical results. Currently they are seldom used.
Classification according to the level of risk in Costa Rica
Dental resins for medical use are considered Class 2 according to rule 2 of Decree 43902-S. The material specifications and/or delivery method do not change this classification of risk.
It is important to clarify that the dental resins mentioned at the beginning of this article differ from those referred to as “resins” used exclusively in dental laboratories for 3D printing. The latter come in block form and are utilized by dental technicians to create molds for pieces commissioned by dentists. These laboratory resins should not be confused with the dental resins described earlier.
Grouping for Sanitary Registration purposes
Different models of resins could be included in the same Sanitary Registration following these considerations:
- All resins must be made by the same manufacturer.
- The intended use of the models must be the same.
- The formula of all models must be the same.
- More than one presentation can be included in the same registration, in which case all the presentations must be indicated in the application.
Conclusions
Securing the sanitary registry for dental medical devices can be complex due to the wide range of available instruments and products. Each device may present variations from standard practices, depending on its specific characteristics and inherent differences. If you need support explaining any one of the requirements described in this article, please contact us at contact@veraqueconsulting.com or check our guidelines.
