FDA product code EHM: Strip, Polishing Agent
EHM is the FDA product code for strip, polishing agent. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EHM, from 2 different applicants. The average 510(k) review took 38 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Strip, Polishing Agent |
| Device class | Class I |
| Regulation | 21 CFR 872.6010 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every EHM clearance
Top EHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teledyne Densco | 1 | 1982-05-28 |
| Howmedica Corp. | 1 | 1979-05-21 |
Most recent EHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K821364 | Teledyne Densco | PROFLEX FLEXIBLE SCALER | 1982-05-28 | 21 |
| K790598 | Howmedica Corp. | RUWA FINISHING STRIPS | 1979-05-21 | 56 |
Recalls for EHM devices
openFDA lists no recalls for product code EHM.
Frequently asked questions
What is FDA product code EHM?
EHM is the FDA product code for strip, polishing agent. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel.
What device class is EHM?
Class I, regulation 21 CFR 872.6010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHM?
Across 2 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most EHM clearances?
Teledyne Densco (1); Howmedica Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHM
- Run a recall and safety report across every EHM manufacturer
- Watch product code EHM 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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