Cytotoxicity testing

[Manel Mou]

Hi
A medical device (denture repairing system) composed of 3 separate components; during clinical use 1 Component is applied on the denture; after curing, 2 other components are mixed by the user and applied on this denture; my question : do you think that cytotoxicity of the MD (denture repairing system) should be evaluated separetely of each of 3 components or we have to test cytotoxicity of the mix of the 3 components ?
Thanks in advance for your support

 

[Nichole F]

I would think you would want to complete testing on the device in its final form. This would be what is coming in contact with the patient (mucosal membranes I'm assuming is applicable to your device). If these are removable dentures, you probably only need to test the final mix. If these are fixed dentures and the three components are being mixed chair-side or are mixed while placing the denture in the patient's mouth, you will likely need to evaluate all three separately and in combination if there is any risk of patient contact. The three components are likely transient contact at best. I'm assuming for a fixed denture contact time is long term. Your testing laboratory should be able to provide guidance for you. While they are out to make a profit, good labs will tell you when a test is not necessary.