FDA product code ECQ: Aligner, Bracket, Orthodontic
ECQ is the FDA product code for aligner, bracket, 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 ECQ, from 2 different applicants. The average 510(k) review took 56 days (median 56). FDA has posted 1 recall for ECQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Aligner, Bracket, 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 ECQ clearance
Top ECQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentauraum, Inc. | 1 | 1994-01-31 |
| A Company, Inc. | 1 | 1985-04-29 |
Most recent ECQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935153 | Dentauraum, Inc. | DENTAURUM BRACKET POSITIONING GAUGE | 1994-01-31 | 95 |
| K851454 | A Company, Inc. | A-COMPANY STAINLESS STEEL ORTHODONTIC BRACKETS | 1985-04-29 | 18 |
Recalls for ECQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-11-13.
Frequently asked questions
What is FDA product code ECQ?
ECQ is the FDA product code for aligner, bracket, orthodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is ECQ?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECQ?
Across 2 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most ECQ clearances?
Dentauraum, Inc. (1); A Company, Inc. (1).
Have ECQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-11-13.
Next steps
- Run an FDA pathway report with predicate devices for product code ECQ
- Run a recall and safety report across every ECQ manufacturer
- Watch product code ECQ 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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