Can I sell boil-and-bite mouthguards on Amazon without a 510(k)? Looking for clarity before I launch

Hey everyone, I’m preparing to launch a boil-and-bite mouthguard product on Amazon. I’ve been doing a lot of research, but I still have a few questions I was hoping experienced sellers or compliance pros here could help clear up: 1. Do I need a 510(k) to sell boil-and-bite mouthguards if I avoid medical claims like “anti-snoring” or “TMJ relief”? 2. Are claims like “nighttime teeth protection” or “custom comfort fit” safe to use on the listing and packaging? 3. Does Amazon automatically block these products if no 510(k) is filed, or is it more about keyword flags and customer reports? 4. Has anyone here sold a basic mouthguard under a general category like “Teeth Grinding Guards” without issues?

I already have FDA registration, ISO docs, 510k exemption number and safety certificates from my supplier — I just want to be 100% clear on whether that’s enough or if I need to go the full 510(k) route before I