Four things to keep in mind when applying for a 510K for dental impression material!
Dental impression material is used to make dental and oral soft and hard tissue impression (negative mould) material.
These products are relatively mature products, widely used in accordance with the material points generally have four kinds: powder
alginate impression material, silicone rubber type impression material, agar type impression material and composite impression
material. According to the nature can be divided into elastic and inelastic, reversible and irreversible impression materials.
According to the requirements of the FDA is required to apply for 510(K) registration.
What should we pay attention to when applying for 510(K) registration for these products?
Concern 1: Selection of Comparison Devices
There are numerous categories of dental impression materials, and you need to find the ones that are most similar to your product.
According to the type of material, such as elastomer, hydrocolloid; according to the working principle, such as the principle of
solidification, the reaction process, etc., corresponding to different products, you need to find the corresponding comparative
instruments to complete the 510K declaration.
Concern 2: Product description
Dental impression materials have many chemical compositions, and it is necessary to clarify the component, CAS number, functional
use and other information of each chemical material, as well as detailed information on how to use the product, including the tools
used in the process.
Concern 3: Validation of expiry date
Dental impression materials need to specify the period for which they can maintain their physical, chemical, biological and
microbiological properties under the influence of certain conditions such as temperature, humidity and light. Provide product
expiration date and expiration date verification information, commonly used accelerated aging verification or real-time aging
verification can be.
Concern 4: Labelling and instructions
Dental impression materials currently on the market are prescription devices and require attention to add prescription labelling.
