FDA product code OGT: Oral Irrigation Kit
OGT is the FDA product code for oral irrigation kit. It is a Class I device, regulated under 21 CFR 872.6510 and reviewed by the Ear, Nose and Throat panel. Devices under OGT 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 | Oral Irrigation Kit |
| Device class | Class I |
| Regulation | 21 CFR 872.6510 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for OGT devices
openFDA lists no recalls for product code OGT.
Frequently asked questions
What is FDA product code OGT?
OGT is the FDA product code for oral irrigation kit. It is a Class I device, regulated under 21 CFR 872.6510 and reviewed by the Ear, Nose and Throat panel.
What device class is OGT?
Class I, regulation 21 CFR 872.6510. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OGT
- Run a recall and safety report across every OGT manufacturer
- Watch product code OGT 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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