1) What are dental crowns? A crown (cap) is a type of dental restoration that fully cups over that portion of a tooth or dental implant that lies at and above the gum line. Once placed, it in effect becomes the tooth's new outer surface. Crowns are permanently cemented into place.
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Under section 736(d)(1)(E) of the Federal Food, Drug and Cosmetic Act the FDA may grant a waiver of the $2,335,200 NDA application fee for the first human drug application that a small business submits for review.