Registration & Listing of a Dental Device - Class Enforcement Descretion

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#1
Hi all,
I am proceeding registration&listing to dental device. Some item fall class "Enforcement Descretion ", FDA says exempt 510K. FDA system do not permit adding product code NSP/NSL... (not classified) to creat new listing. How to do add them?
 
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#4
I ask for FDA help. They instruct me to enter the words " enforcement discretion" when prompted to enter sumbmission type. The System does not still accept and warn "invalid submission number. If you know how to do, give me advice. Thanks a lot
 
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MIREGMGR

#5
In different posts, you've spelled "discretion" two ways. Did you spell it correctly when entering it into the database?

I haven't had occasion to try what you're doing because we don't have any such devices, but I can envision that a filter might only accept such a text entry when spelled right.

If that's not it, you might call them back and ask for further help.
 
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#6
Another FDA assistant said not to enter full word "enforcement discretion" but only "enforcement" enough. Finally the system accept and I made successful listing.
 
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