Crown and Bridge, Long-Term Temporary, Resin

What Is It?

For the fabrication of long-term temporary crowns and bridges

How Is POW Classified?

Crown And Bridge, Long-Term Temporary, Resin is FDA product code POW, Class 2, 21 CFR 872.3770.

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. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.