FDA product code EKC: Excavator, Dental, Operative
EKC is the FDA product code for excavator, dental, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EKC, from 2 different applicants. The average 510(k) review took 79 days (median 79). FDA has posted 8 recalls for EKC devices.
Classification
| Field | Value |
|---|---|
| Device name | Excavator, Dental, Operative |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Top EKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-07-02 |
| Henry Schein, Inc. | 1 | 1984-02-21 |
Most recent EKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851722 | Artiberia | 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS | 1985-07-02 | 68 |
| K834055 | Henry Schein, Inc. | VANADIUM EXCAVATORS SIZES 0-6 | 1984-02-21 | 90 |
Recalls for EKC devices
8 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-11-14.
Frequently asked questions
What is FDA product code EKC?
EKC is the FDA product code for excavator, dental, operative. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKC?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKC?
Across 2 cleared submissions the average was 79 days from receipt to decision (median 79).
Which companies have the most EKC clearances?
Artiberia (1); Henry Schein, Inc. (1).
Have EKC devices been recalled?
Yes: 8 product recalls across 1 recall events; the most recent began 2008-11-14.
Next steps
- Run an FDA pathway report with predicate devices for product code EKC
- Run a recall and safety report across every EKC manufacturer
- Watch product code EKC 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.