Sealant, Pit and Fissure, and Conditioner

How Is EBC Classified?

Sealant, Pit And Fissure, And Conditioner is FDA product code EBC, Class 2, 21 CFR 872.3765.

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 1 clearance under this code; the FDA took 154 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Mixed-up of materials/components (1) and Labeling mix-ups (1).

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