FDA product code ECI: Band, Elastic, Orthodontic
ECI is the FDA product code for band, elastic, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 25 510(k) submissions under ECI, from 15 different applicants. The average 510(k) review took 144 days (median 108). FDA has posted 3 recalls for ECI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Band, Elastic, 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 ECI clearance
Top ECI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A Company, Inc. | 5 | 1985-07-31 |
| Jon-Ko Products, Inc. | 4 | 1995-05-24 |
| Glenroe Technologies | 3 | 1998-02-24 |
| Unitek Corp. | 2 | 1994-03-07 |
| Ortho Kinetics Corp. | 1 | 1998-04-20 |
10 more applicants have ECI clearances. See the full list in Caduvo.
Most recent ECI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980864 | Ortho Kinetics Corp. | POWER COINS GLOW IN THE DARK LIGATURES | 1998-04-20 | 46 |
| K980053 | Glenroe Technologies | GLENROE CHAIN | 1998-02-24 | 49 |
| K973495 | Glenroe | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | 1997-12-01 | 76 |
| K943419 | Jon-Ko Products, Inc. | ORTHODONTIC ELASTOMERIC LAGATURE MODULE | 1995-05-24 | 313 |
| K943420 | Jon-Ko Products, Inc. | ORTHODONTIC ELASTOMERIC CHAIN | 1995-05-23 | 312 |
Recalls for ECI devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-21.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code ECI?
ECI is the FDA product code for band, elastic, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is ECI?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECI?
Across 25 cleared submissions the average was 144 days from receipt to decision (median 108).
Which companies have the most ECI clearances?
A Company, Inc. (5); Jon-Ko Products, Inc. (4); Glenroe Technologies (3); Unitek Corp. (2); Ortho Kinetics Corp. (1).
Have ECI devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2023-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code ECI
- Run a recall and safety report across every ECI manufacturer
- Watch product code ECI 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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