FDA product code ECS: Pusher, Band, Orthodontic
ECS is the FDA product code for pusher, band, orthodontic. 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 ECS, from 2 different applicants. The average 510(k) review took 77 days (median 77).
Classification
| Field | Value |
|---|---|
| Device name | Pusher, Band, Orthodontic |
| 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 ECS clearance
Top ECS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentauraum, Inc. | 1 | 1994-02-04 |
| Glenroe Technologies | 1 | 1992-11-25 |
Most recent ECS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935155 | Dentauraum, Inc. | MERSHON BAND PUSHER | 1994-02-04 | 99 |
| K924993 | Glenroe Technologies | GLENROE BAND SEATING CONTOURING INSTRUMENT | 1992-11-25 | 55 |
Recalls for ECS devices
openFDA lists no recalls for product code ECS.
Frequently asked questions
What is FDA product code ECS?
ECS is the FDA product code for pusher, band, orthodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is ECS?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECS?
Across 2 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most ECS clearances?
Dentauraum, Inc. (1); Glenroe Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ECS
- Run a recall and safety report across every ECS manufacturer
- Watch product code ECS 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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