FDA product code EHE: Dispenser, Mercury And/Or Alloy
EHE is the FDA product code for dispenser, mercury and/or alloy. It is a Class I device, regulated under 21 CFR 872.3080 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EHE, from 2 different applicants. The average 510(k) review took 10 days (median 10).
Classification
| Field | Value |
|---|---|
| Device name | Dispenser, Mercury And/Or Alloy |
| Device class | Class I |
| Regulation | 21 CFR 872.3080 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EHE clearance
Top EHE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| New Dimensions IN Medicine, Inc. | 1 | 1977-09-28 |
| Johnson & Johnson Professionals, Inc. | 1 | 1977-08-03 |
Most recent EHE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771749 | New Dimensions IN Medicine, Inc. | AMALGAM DISPENSER | 1977-09-28 | 13 |
| K771396 | Johnson & Johnson Professionals, Inc. | DISPENSER, MERCURY & TABLET/POWDER | 1977-08-03 | 6 |
Recalls for EHE devices
openFDA lists no recalls for product code EHE.
Frequently asked questions
What is FDA product code EHE?
EHE is the FDA product code for dispenser, mercury and/or alloy. It is a Class I device, regulated under 21 CFR 872.3080 and reviewed by the Dental panel.
What device class is EHE?
Class I, regulation 21 CFR 872.3080. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHE?
Across 2 cleared submissions the average was 10 days from receipt to decision (median 10).
Which companies have the most EHE clearances?
New Dimensions IN Medicine, Inc. (1); Johnson & Johnson Professionals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHE
- Run a recall and safety report across every EHE manufacturer
- Watch product code EHE 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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