FDA product code OFY: Dental Implant Surgical Tray
OFY is the FDA product code for dental implant surgical tray. It is a Class I device, regulated under 21 CFR 872.3980 and reviewed by the Dental panel. Devices under OFY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OFY devices.
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 | Dental Implant Surgical Tray |
| Device class | Class I |
| Regulation | 21 CFR 872.3980 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for OFY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-05-18.
Frequently asked questions
What is FDA product code OFY?
OFY is the FDA product code for dental implant surgical tray. It is a Class I device, regulated under 21 CFR 872.3980 and reviewed by the Dental panel.
What device class is OFY?
Class I, regulation 21 CFR 872.3980. Typical premarket route: 510(k) exempt.
Have OFY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code OFY
- Run a recall and safety report across every OFY manufacturer
- Watch product code OFY 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.
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