FDA product code EHO: Bar, Preformed
EHO is the FDA product code for bar, preformed. It is a Class I device, regulated under 21 CFR 872.3165 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EHO, from 3 different applicants. The average 510(k) review took 292 days (median 329).
Classification
| Field | Value |
|---|---|
| Device name | Bar, Preformed |
| Device class | Class I |
| Regulation | 21 CFR 872.3165 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EHO clearance
Top EHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gatewood Splints | 1 | 1994-08-05 |
| Trophy Radiologie | 1 | 1989-07-20 |
| Dale T. Dupuis | 1 | 1988-10-06 |
Most recent EHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934468 | Gatewood Splints | SLIP-ON FIXATION SPLINT (SFS) | 1994-08-05 | 329 |
| K881133 | Trophy Radiologie | 70-X/RVG (RADIOVISIOGRAPHY) | 1989-07-20 | 491 |
| K883388 | Dale T. Dupuis | DENTREK BRIDGE BARS | 1988-10-06 | 57 |
Recalls for EHO devices
openFDA lists no recalls for product code EHO.
Frequently asked questions
What is FDA product code EHO?
EHO is the FDA product code for bar, preformed. It is a Class I device, regulated under 21 CFR 872.3165 and reviewed by the Dental panel.
What device class is EHO?
Class I, regulation 21 CFR 872.3165. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHO?
Across 3 cleared submissions the average was 292 days from receipt to decision (median 329).
Which companies have the most EHO clearances?
Gatewood Splints (1); Trophy Radiologie (1); Dale T. Dupuis (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHO
- Run a recall and safety report across every EHO manufacturer
- Watch product code EHO 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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