FDA product code EKS: File, Pulp Canal, Endodontic
EKS is the FDA product code for file, pulp canal, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 31 510(k) submissions under EKS, from 25 different applicants. The average 510(k) review took 83 days (median 57). FDA has posted 3 recalls for EKS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | File, Pulp 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 EKS clearance
Top EKS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Union Broach, Div. Moyco Industries, Inc. | 4 | 1994-01-03 |
| Tycom Dental | 2 | 1997-05-22 |
| United Dental Mfg., Inc. | 2 | 1982-12-28 |
| Miltex, Inc. | 2 | 1982-11-24 |
| Ormco Corp. | 1 | 2006-12-13 |
20 more applicants have EKS clearances. See the full list in Caduvo.
Most recent EKS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062856 | Ormco Corp. | TF ROTARY NICKEL TITANIUM FILE | 2006-12-13 | 79 |
| K004031 | Dental Power, Inc. | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES | 2001-03-28 | 90 |
| K971319 | Tycom Dental | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES | 1997-05-22 | 42 |
| K970649 | Micro-Mega | HERO 642 | 1997-05-16 | 85 |
| K962031 | Tycom Dental | QUANTEC SERIES 2000 ENDODONTIC FILES | 1996-06-04 | 11 |
Recalls for EKS devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-01-02.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code EKS?
EKS is the FDA product code for file, pulp canal, endodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EKS?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKS?
Across 31 cleared submissions the average was 83 days from receipt to decision (median 57).
Which companies have the most EKS clearances?
Union Broach, Div. Moyco Industries, Inc. (4); Tycom Dental (2); United Dental Mfg., Inc. (2); Miltex, Inc. (2); Ormco Corp. (1).
Have EKS devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code EKS
- Run a recall and safety report across every EKS manufacturer
- Watch product code EKS 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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