FDA product code ELY: Mercury
ELY is the FDA product code for mercury. It is a Class II device, regulated under 21 CFR 872.3070 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under ELY, from 4 different applicants. The average 510(k) review took 105 days (median 103).
Classification
| Field | Value |
|---|---|
| Device name | Mercury |
| Device class | Class II |
| Regulation | 21 CFR 872.3070 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every ELY clearance
Top ELY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dmg USA, Inc. | 1 | 2010-01-21 |
| Aleaciones Dentales Zeyco, S.A. DE C.V. | 1 | 1998-03-23 |
| National Health-Care Equipment, Inc. | 1 | 1992-01-16 |
| Degussa AG | 1 | 1990-06-28 |
Most recent ELY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093587 | Dmg USA, Inc. | DENTAL MERCURY | 2010-01-21 | 63 |
| K973548 | Aleaciones Dentales Zeyco, S.A. DE C.V. | MERCURY DENTAL | 1998-03-23 | 186 |
| K913814 | National Health-Care Equipment, Inc. | MODEL #05 ANEROID SPHYGMOMANOMETER KIT | 1992-01-16 | 143 |
| K902388 | Degussa AG | DENTAL-QUECKSILBER (DENTAL MERCURY) | 1990-06-28 | 29 |
Recalls for ELY devices
openFDA lists no recalls for product code ELY.
Frequently asked questions
What is FDA product code ELY?
ELY is the FDA product code for mercury. It is a Class II device, regulated under 21 CFR 872.3070 and reviewed by the Dental panel.
What device class is ELY?
Class II, regulation 21 CFR 872.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code ELY?
Across 4 cleared submissions the average was 105 days from receipt to decision (median 103).
Which companies have the most ELY clearances?
Dmg USA, Inc. (1); Aleaciones Dentales Zeyco, S.A. DE C.V. (1); National Health-Care Equipment, Inc. (1); Degussa AG (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ELY
- Run a recall and safety report across every ELY manufacturer
- Watch product code ELY 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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