Dear all,
We manufacture a dental cartridge syringe which is single use and made of medical grade plastic. On looking at the regulatory requirements on the FDA website, I found that dental cartridge have a product code of EJI. The descriptions states the syringe has a metal body. Would we be able to use the same regulatory route given the different materials used? Also the metal syringe is reused while ours is single use.
The product is registered in the EU as a class 1 medical device (non-sterile and non-measuring). Bio compatibility and shelf life testing has been done.
Advice is appreciated. Also calling for any experts who can assist in obtaining FDA approvals.
We manufacture a dental cartridge syringe which is single use and made of medical grade plastic. On looking at the regulatory requirements on the FDA website, I found that dental cartridge have a product code of EJI. The descriptions states the syringe has a metal body. Would we be able to use the same regulatory route given the different materials used? Also the metal syringe is reused while ours is single use.
The product is registered in the EU as a class 1 medical device (non-sterile and non-measuring). Bio compatibility and shelf life testing has been done.
Advice is appreciated. Also calling for any experts who can assist in obtaining FDA approvals.
