Resin, Denture, Relining, Repairing, Rebasing

What Is FDA Product Code EBI?

Resin, Denture, Relining, Repairing, Rebasing is FDA product code EBI, Class 2, 21 CFR 872.3760.

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 73 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 16 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Software design (5), Material/Component Contamination (5) and Nonconforming Material/Component (3).

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