FDA product code EKH: Carver, Dental Amalgam, Operative
EKH is the FDA product code for carver, dental amalgam, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EKH, from 3 different applicants. The average 510(k) review took 17 days (median 16). FDA has posted 1 recall for EKH devices.
Classification
| Field | Value |
|---|---|
| Device name | Carver, Dental Amalgam, Operative |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EKH clearance
Top EKH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miltex, Inc. | 1 | 1982-11-24 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
| Premier Dental Products Co. | 1 | 1978-04-19 |
Most recent EKH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K823321 | Miltex, Inc. | DENTAL INSTRUMENTS - CARVER | 1982-11-24 | 16 |
| K821785 | Pacific Dental Corp. | BEACH AMALGAM CARVER | 1982-07-06 | 19 |
| K780528 | Premier Dental Products Co. | PREMIER CARVERS, STYLE #21C & 21D | 1978-04-19 | 16 |
Recalls for EKH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-20.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code EKH?
EKH is the FDA product code for carver, dental amalgam, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKH?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKH?
Across 3 cleared submissions the average was 17 days from receipt to decision (median 16).
Which companies have the most EKH clearances?
Miltex, Inc. (1); Pacific Dental Corp. (1); Premier Dental Products Co. (1).
Have EKH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-04-20.
Next steps
- Run an FDA pathway report with predicate devices for product code EKH
- Run a recall and safety report across every EKH manufacturer
- Watch product code EKH 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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