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The FDA has Mouthguards as MQC product code Mouthguard (prescription). This is a Preamendment device, so it is not classified.
There a total of 67 cleared 510k's for the MQC product code.
Reviewing the 510k summaries, there are a total of 30 cleared for the materials used to build mouthguards. (material only, no device)
There are a total of 23 cleared 510k's for mouthguard devices with additional pro codes which include over the counter (pro code OBR) and Rx mouthguards with a expanded indication (pro code OCO).
There are 14 cleared standalone mouthguard device (MQC) 510k's, and of those only 2 cleared 510k's in the last 7 years.
This seems like a very small number of companies cleared to manufacture mouthguards (at least Rx mouthguards). I know that most Rx mouthguards are produced in a dental lab, and there are very few dental labs listed under this product code. Hmmm. Something is not adding up here.
For a medical device manufacturer wanting to produce mouthguards (MQC), is a 510k submission required?
I would appreciate any feedback from those that have experience in this product space.
Thank you.