FDA product code OFW: Restorative Instrument And Component Tray
OFW is the FDA product code for restorative instrument and component tray. It is a Class II device, regulated under 21 CFR 872.3690 and reviewed by the Dental panel. Devices under OFW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Restorative Instrument And Component Tray |
| Device class | Class II |
| Regulation | 21 CFR 872.3690 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for OFW devices
openFDA lists no recalls for product code OFW.
Frequently asked questions
What is FDA product code OFW?
OFW is the FDA product code for restorative instrument and component tray. It is a Class II device, regulated under 21 CFR 872.3690 and reviewed by the Dental panel.
What device class is OFW?
Class II, regulation 21 CFR 872.3690. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OFW
- Run a recall and safety report across every OFW manufacturer
- Watch product code OFW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.