Crown and Bridge, Temporary, Resin

What Is FDA Product Code EBG?

Crown And Bridge, Temporary, Resin is FDA product code EBG, Class 2, 21 CFR 872.3770.

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 9 clearances under this code; the FDA took a median of 134 days from receipt to decision on them.

1 was reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Labeling mix-ups (1) and Employee error (1).

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