Powder, Porcelain

What Is FDA Product Code EIH?

Powder, Porcelain is FDA product code EIH, Class 2, 21 CFR 872.6660.

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 57 clearances under this code; the FDA took a median of 91 days from receipt to decision on them.

3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 1 was reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 35 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Process design (21), Process control (5) and Nonconforming Material/Component (1).

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