FDA product code OFX: General Purpose Dental Tray

OFX is the FDA product code for general purpose dental tray. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel. Devices under OFX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 21 recalls for OFX devices, 20 initiated in the last five years.

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

Recalls for OFX devices

21 product recalls in 19 recall events; 20 initiated in the last five years and 20 still open. Most recent: 2026-07-29.

Frequently asked questions

What is FDA product code OFX?

OFX is the FDA product code for general purpose dental tray. It is a Class I device, regulated under 21 CFR 872.6640 and reviewed by the Dental panel.

What device class is OFX?

Class I, regulation 21 CFR 872.6640. Typical premarket route: 510(k) exempt.

Have OFX devices been recalled?

Yes: 21 product recalls across 19 recall events; the most recent began 2026-07-29.

Next steps

• Run an FDA pathway report with predicate devices for product code OFX
• Run a recall and safety report across every OFX manufacturer
• Watch product code OFX 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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