Amazon requesting 510(k) number issued by the United States Food and Drug Administration (FDA) for this product

Account Health Restricted Products
1

Hello everyone.

I have a small problem and was hoping to solve it this way. I created a listing to sell “false teeth veneers” on amazon. Two weeks ago I got a notification from amazon that my listing was being removed as they need additional info.

This is the message I received from Amazon:

To reactivate your ASINs, send the following documentation and information:

– Photos of all the sides of the product packaging. All 6 sides are required

– Photos of the instructions included with the product. Complete user manual is required.

– The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product.

If the product does not require a 510(k), provide an explanation along with proof to support the 510(K) claim exemption

despite my listing being removed, it didn’t seem complex to reactivate it. Mainly I can tell from Amazon’s message that they need photos/instructions of the product and the 510(k) number issued by the FDA.

About the pictures:

  • I have added the necessary photos to my defence. Photos where the packaging, instructions and the product itself is visible.

Regarding the 510(k) number issued by the FDA:

  • Since the veneers are a class 2 product according to the FDA, we do not require a a 510 (k) I have also included the 510 (k) evidence in the attachment. This receipt shows the 510(k) exempt code.

Several days later i get the following message again from Amazon seller support:

Hello,

We received your appeal for the ASINs B0C3WG48KJ, but we are unable to reactivate your ASINs at this time.

What actions do I need to take?

To reactivate your ASINs, send the following documentation and information:

– Photos of all the sides of the product packaging. All 6 sides are required

– Photos of the instructions included with the product. Complete user manual is required.

– The 510(k) number issued by the United States Food and Drug Administration (FDA) for this product.

I keep getting the same message again from seller support like i received before. Can anyone help me with this issue? Is there something i’m missing? Because i would think that i’ve submitted al the information that’s needed to reactivate back my listing. I will be very grateful for your help because at the moment I don’t know what to do with this matter.

Many thanks

2

Unless you are a seller based out of China you will have a difficult time getting that listed.
Playing semantics does not work for USA based sellers. Those veneers can be applied to live human teeth as well.

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3

Check the 510(k) number you provided. Make sure it is the correct number for the product that you are selling.

Retake the photos of the product packaging and instructions. Make sure the photos are clear and in focus, and that all six sides of the packaging are visible.

And try it again, many times amazon didn’t accept your query in the first attempt so try it another time.

4 Likes
4

OR, sell it on ebay, all the sellers from China have veneers listed with a starting price of $5.97 and FREE SHIPPING.

Looks like that is the kind of item that would sell good in a quick mart.

Also, the plastic must be approved for human contact. I highly doubt that any of them sold on eBay are legal to sell. Even the super glue they use must be approved, NO WAY, at $5.95.

5 Likes
5

You will have to provide all the documents and FDA certificates to ungate this category

6

You need to come up with more documents. Instead of sending appeal again n again without solid grounds, will not work. For better understanding needs more clearification.

2 Likes