FDA product code ECR: Setter, Band, Orthodontic
ECR is the FDA product code for setter, band, orthodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under ECR, from 3 different applicants. The average 510(k) review took 65 days (median 57).
Classification
| Field | Value |
|---|---|
| Device name | Setter, 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 ECR clearance
Top ECR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ormco Corp. | 1 | 1995-05-23 |
| Dentauraum, Inc. | 1 | 1994-02-03 |
| Essential Dental Systems, Inc. | 1 | 1984-09-27 |
Most recent ECR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K951776 | Ormco Corp. | BAND SEATER | 1995-05-23 | 40 |
| K935156 | Dentauraum, Inc. | DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS | 1994-02-03 | 98 |
| K843018 | Essential Dental Systems, Inc. | FLEXI-POST | 1984-09-27 | 57 |
Recalls for ECR devices
openFDA lists no recalls for product code ECR.
Frequently asked questions
What is FDA product code ECR?
ECR is the FDA product code for setter, band, orthodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is ECR?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECR?
Across 3 cleared submissions the average was 65 days from receipt to decision (median 57).
Which companies have the most ECR clearances?
Ormco Corp. (1); Dentauraum, Inc. (1); Essential Dental Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ECR
- Run a recall and safety report across every ECR manufacturer
- Watch product code ECR 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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