Dental Implant Surgical Tray

What Is This Device?

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 OFY Classified?

Dental Implant Surgical Tray is FDA product code OFY, Class 1, 21 CFR 872.3980.

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 Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2010. None was by a company in China. The root cause the FDA records most often is Labeling design (1).

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