FDA product code EJF: Bracket, Metal, Orthodontic
EJF is the FDA product code for bracket, metal, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel. FDA has cleared 103 510(k) submissions under EJF, from 46 different applicants. The average 510(k) review took 119 days (median 75). FDA has posted 8 recalls for EJF devices.
Classification
| Field | Value |
|---|---|
| Device name | Bracket, Metal, 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 EJF clearance
Top EJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Orthodontics | 22 | 1993-09-13 |
| Ormco Corp. | 8 | 1993-10-20 |
| Lancer Orthodontics, Inc. | 7 | 1990-11-09 |
| Flexmedics | 7 | 1989-01-10 |
| Gac Intl., Inc. | 5 | 1994-05-09 |
41 more applicants have EJF clearances. See the full list in Caduvo.
Most recent EJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K994357 | Thermoelastic Technologies, Inc. | BITEM LOCK, MODELS SW006, SW012 | 2000-03-14 | 78 |
| K932825 | Gac Intl., Inc. | MICROARCH GOLD BRACKET | 1994-05-09 | 334 |
| K933501 | Unitek Corp. | ALASTIK | 1994-04-28 | 283 |
| K923372 | Althan, Inc. | MEMORY WIRE | 1994-04-22 | 652 |
| K933080 | Orthotech | ORTHOTECH DURA-GOLD BARCKETS | 1994-03-23 | 273 |
Recalls for EJF devices
8 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-01-14.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code EJF?
EJF is the FDA product code for bracket, metal, orthodontic. It is a Class I device, regulated under 21 CFR 872.5410 and reviewed by the Dental panel.
What device class is EJF?
Class I, regulation 21 CFR 872.5410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJF?
Across 103 cleared submissions the average was 119 days from receipt to decision (median 75).
Which companies have the most EJF clearances?
American Orthodontics (22); Ormco Corp. (8); Lancer Orthodontics, Inc. (7); Flexmedics (7); Gac Intl., Inc. (5).
Have EJF devices been recalled?
Yes: 8 product recalls across 7 recall events; the most recent began 2020-01-14.
Next steps
- Run an FDA pathway report with predicate devices for product code EJF
- Run a recall and safety report across every EJF manufacturer
- Watch product code EJF 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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