FDA product code ECO: Spring, Orthodontic
ECO is the FDA product code for spring, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under ECO, from 6 different applicants. The average 510(k) review took 108 days (median 64). FDA has posted 13 recalls for ECO devices.
Classification
| Field | Value |
|---|---|
| Device name | Spring, Orthodontic |
| Device class | Class I |
| Regulation | 21 CFR 872.5410 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ECO clearance
Top ECO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Active Vertical Correctors, Inc. | 2 | 1985-01-04 |
| Ormco Corp. | 1 | 1994-08-17 |
| Gac Intl., Inc. | 1 | 1994-08-05 |
| Orthoplus, Inc. | 1 | 1994-07-13 |
| Medical Magnetics, Inc. | 1 | 1984-12-21 |
1 more applicants have ECO clearances. See the full list in Caduvo.
Most recent ECO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943068 | Ormco Corp. | MAGNEFORCE | 1994-08-17 | 50 |
| K933542 | Gac Intl., Inc. | MESIAL LOOP BAR | 1994-08-05 | 381 |
| K942492 | Orthoplus, Inc. | ADJUSTABLE BITE CORRECTOR | 1994-07-13 | 49 |
| K844234 | Active Vertical Correctors, Inc. | ACTIVE VERTICAL CORRECTOR APPLIANCE | 1985-01-04 | 64 |
| K843550 | Medical Magnetics, Inc. | ORTHOMAG MAGNETIC FORCE SYSTEM | 1984-12-21 | 102 |
Recalls for ECO devices
13 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-01.
| Year | Recalls |
|---|---|
| 2018 | 13 |
Frequently asked questions
What is FDA product code ECO?
ECO is the FDA product code for spring, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is ECO?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECO?
Across 7 cleared submissions the average was 108 days from receipt to decision (median 64).
Which companies have the most ECO clearances?
Active Vertical Correctors, Inc. (2); Ormco Corp. (1); Gac Intl., Inc. (1); Orthoplus, Inc. (1); Medical Magnetics, Inc. (1).
Have ECO devices been recalled?
Yes: 13 product recalls across 1 recall events; the most recent began 2018-05-01.
Next steps
- Run an FDA pathway report with predicate devices for product code ECO
- Run a recall and safety report across every ECO manufacturer
- Watch product code ECO 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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