FDA product code EMO: Knife, Periodontic
EMO is the FDA product code for knife, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. Devices under EMO reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for EMO devices.
Classification
| Field | Value |
|---|---|
| Device name | Knife, Periodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for EMO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-03-28.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code EMO?
EMO is the FDA product code for knife, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMO?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
Have EMO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-03-28.
Next steps
- Run an FDA pathway report with predicate devices for product code EMO
- Run a recall and safety report across every EMO manufacturer
- Watch product code EMO 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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