FDA product code ECM: Band, Preformed, Orthodontic
ECM is the FDA product code for band, preformed, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under ECM, from 2 different applicants. The average 510(k) review took 153 days (median 153).
Classification
| Field | Value |
|---|---|
| Device name | Band, Preformed, Orthodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.5410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Top ECM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unicep | 1 | 1993-05-27 |
| Titane SL Co. | 1 | 1987-09-11 |
Most recent ECM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K925163 | Unicep | MICODOSE CHLORHEXIPREP | 1993-05-27 | 226 |
| K872471 | Titane SL Co. | TITANE SL DENTAL BURR | 1987-09-11 | 80 |
Recalls for ECM devices
openFDA lists no recalls for product code ECM.
Frequently asked questions
What is FDA product code ECM?
ECM is the FDA product code for band, preformed, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is ECM?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECM?
Across 2 cleared submissions the average was 153 days from receipt to decision (median 153).
Which companies have the most ECM clearances?
Unicep (1); Titane SL Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ECM
- Run a recall and safety report across every ECM manufacturer
- Watch product code ECM 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.