FDA product code EKG: Condenser, Amalgam And Foil, Operative
EKG is the FDA product code for condenser, amalgam and foil, 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 EKG, from 3 different applicants. The average 510(k) review took 45 days (median 58).
Classification
| Field | Value |
|---|---|
| Device name | Condenser, Amalgam And Foil, 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 EKG clearance
Top EKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Austenal Dental, Inc. | 1 | 1987-02-19 |
| Shofu Dental Corp. | 1 | 1984-12-03 |
| Miltex, Inc. | 1 | 1982-11-24 |
Most recent EKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K865025 | Austenal Dental, Inc. | AUSTENAL CONDENSING INSTRUMENT | 1987-02-19 | 58 |
| K843901 | Shofu Dental Corp. | ISOSTATIC CONDENSER | 1984-12-03 | 61 |
| K823322 | Miltex, Inc. | DENTAL INSTRUMENTS - PLUGGERS | 1982-11-24 | 16 |
Recalls for EKG devices
openFDA lists no recalls for product code EKG.
Frequently asked questions
What is FDA product code EKG?
EKG is the FDA product code for condenser, amalgam and foil, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKG?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKG?
Across 3 cleared submissions the average was 45 days from receipt to decision (median 58).
Which companies have the most EKG clearances?
Austenal Dental, Inc. (1); Shofu Dental Corp. (1); Miltex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKG
- Run a recall and safety report across every EKG manufacturer
- Watch product code EKG 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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