Varnish, Cavity

How Is LBH Classified?

Varnish, Cavity is FDA product code LBH, Class 2, 21 CFR 872.3260.

What Does It Take to Sell It in the United States?

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 2 clearances under this code; the FDA took a median of 253 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 9 recalls under this product code since 2014. None was by a company in China. The root causes the FDA records most often are Mixed-up of materials/components (3), No Marketing Application (2) and Process control (2).

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