General Purpose Dental Tray

What Is It?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

How Is OFX Classified?

General Purpose Dental Tray is FDA product code OFX, Class 1, 21 CFR 872.6640.

How Does It Reach the US Market?

The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.

What Has Gone Wrong With It?

The FDA has recorded 21 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Process control (4), Packaging process control (3) 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.