FDA product code EKM: Gutta-Percha
EKM is the FDA product code for gutta-percha. It is a Class I device, regulated under 21 CFR 872.3850 and reviewed by the Dental panel. FDA has cleared 23 510(k) submissions under EKM, from 15 different applicants. The average 510(k) review took 87 days (median 57). FDA has posted 3 recalls for EKM devices.
Classification
| Field | Value |
|---|---|
| Device name | Gutta-Percha |
| Device class | Class I |
| Regulation | 21 CFR 872.3850 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EKM clearance
Top EKM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tulsa Dental Products, Ltd. | 4 | 1997-03-21 |
| Endo Twinn B.V. | 2 | 2007-02-16 |
| Dr. Howard Martin, P.A. | 2 | 2006-06-26 |
| Analytic Technology | 2 | 1992-01-21 |
| Endodent, Inc. | 2 | 1986-10-30 |
10 more applicants have EKM clearances. See the full list in Caduvo.
Most recent EKM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K073369 | Hu-Friedy Mfg. Co., Inc. | EI DOWNPAK BARRIER SLEEVES | 2008-02-27 | 89 |
| K070246 | Endo Twinn B.V. | DOWN PAK | 2007-02-16 | 22 |
| K051573 | Dr. Howard Martin, P.A. | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | 2006-06-26 | 377 |
| K042870 | Endo Twinn B.V. | ENDO TWINN | 2005-01-11 | 85 |
| K023819 | Pentron Clinical Technologies | FIBERFILL SGP | 2003-03-26 | 131 |
Recalls for EKM devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-08.
Frequently asked questions
What is FDA product code EKM?
EKM is the FDA product code for gutta-percha. It is a Class I device, regulated under 21 CFR 872.3850 and reviewed by the Dental panel.
What device class is EKM?
Class I, regulation 21 CFR 872.3850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EKM?
Across 23 cleared submissions the average was 87 days from receipt to decision (median 57).
Which companies have the most EKM clearances?
Tulsa Dental Products, Ltd. (4); Endo Twinn B.V. (2); Dr. Howard Martin, P.A. (2); Analytic Technology (2); Endodent, Inc. (2).
Have EKM devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2016-02-08.
Next steps
- Run an FDA pathway report with predicate devices for product code EKM
- Run a recall and safety report across every EKM manufacturer
- Watch product code EKM 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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