Material, Tooth Shade, Resin

What Is FDA Product Code EBF?

Material, Tooth Shade, Resin is FDA product code EBF, Class 2, 21 CFR 872.3690.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 14 clearances under this code; the FDA took a median of 94 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 3 were reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 71 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Component design/selection (42), Nonconforming Material/Component (16) and Material/Component Contamination (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.