FDA product code OCO: Mouthguard, Migraine/Tension Headache
OCO is the FDA product code for mouthguard, migraine/tension headache. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under OCO, from 3 different applicants. The average 510(k) review took 182 days (median 161).
Definition
A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular activity, and; For the prevention of bruxism and tmj syndrome through reduction of trigeminally innervated muscular activity.
Classification
| Field | Value |
|---|---|
| Device name | Mouthguard, Migraine/Tension Headache |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for OCO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 296 |
Compare with all 510(k) review times · Search every OCO clearance
Top OCO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Moonwalker Innovations, Inc. | 1 | 2021-06-24 |
| Luco Hybrid Osa Appliance, Inc. | 1 | 2016-07-29 |
| Nti-Tss, Inc. | 1 | 2001-06-20 |
Most recent OCO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202523 | Moonwalker Innovations, Inc. | TMJ Relax | 2021-06-24 | 296 |
| K160477 | Luco Hybrid Osa Appliance, Inc. | The Luco Hybrid OSA Appliance | 2016-07-29 | 161 |
| K010876 | Nti-Tss, Inc. | NTI TENSION SUPPRESSION SYSTEM | 2001-06-20 | 89 |
Recalls for OCO devices
openFDA lists no recalls for product code OCO.
Frequently asked questions
What is FDA product code OCO?
OCO is the FDA product code for mouthguard, migraine/tension headache. It is a Unclassified device, reviewed by the Dental panel.
What device class is OCO?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCO?
Across 3 cleared submissions the average was 182 days from receipt to decision (median 161).
Which companies have the most OCO clearances?
Moonwalker Innovations, Inc. (1); Luco Hybrid Osa Appliance, Inc. (1); Nti-Tss, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OCO
- Run a recall and safety report across every OCO manufacturer
- Watch product code OCO 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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