FDA product code EKQ: Preparer, Root Canal Endodontic
EKQ is the FDA product code for preparer, root canal endodontic. 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 EKQ, from 2 different applicants. The average 510(k) review took 52 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Preparer, Root Canal Endodontic |
| 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 EKQ clearance
Top EKQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syntex Dental Products, Inc. | 1 | 1983-10-04 |
| Almore Intl., Inc. | 1 | 1980-07-21 |
Most recent EKQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832378 | Syntex Dental Products, Inc. | VIBRATORY ENDODONTIC SYSTEM | 1983-10-04 | 77 |
| K801463 | Almore Intl., Inc. | OJ-1 ENDODONIC ROOT CANAL FILE HOLDER | 1980-07-21 | 27 |
Recalls for EKQ devices
openFDA lists no recalls for product code EKQ.
Frequently asked questions
What is FDA product code EKQ?
EKQ is the FDA product code for preparer, root canal endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKQ?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKQ?
Across 2 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most EKQ clearances?
Syntex Dental Products, Inc. (1); Almore Intl., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EKQ
- Run a recall and safety report across every EKQ manufacturer
- Watch product code EKQ 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times