FDA product code EHS: Cushion, Denture, Over The Counter
EHS is the FDA product code for cushion, denture, over the counter. It is a Class II device, regulated under 21 CFR 872.3540 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EHS, from 3 different applicants. The average 510(k) review took 104 days (median 112).
Classification
| Field | Value |
|---|---|
| Device name | Cushion, Denture, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 872.3540 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EHS clearance
Top EHS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lloyd V. Ziemendorf | 1 | 1997-07-15 |
| Leonard Russo Co. | 1 | 1982-02-05 |
| Combe, Inc. | 1 | 1977-06-24 |
Most recent EHS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971002 | Lloyd V. Ziemendorf | SMILE WITH CONFIDENCE | 1997-07-15 | 118 |
| K813190 | Leonard Russo Co. | SOFT PLATE CUSHION | 1982-02-05 | 81 |
| K770413 | Combe, Inc. | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | 1977-06-24 | 112 |
Recalls for EHS devices
openFDA lists no recalls for product code EHS.
Frequently asked questions
What is FDA product code EHS?
EHS is the FDA product code for cushion, denture, over the counter. It is a Class II device, regulated under 21 CFR 872.3540 and reviewed by the Dental panel.
What device class is EHS?
Class II, regulation 21 CFR 872.3540. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHS?
Across 3 cleared submissions the average was 104 days from receipt to decision (median 112).
Which companies have the most EHS clearances?
Lloyd V. Ziemendorf (1); Leonard Russo Co. (1); Combe, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHS
- Run a recall and safety report across every EHS manufacturer
- Watch product code EHS 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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