FDA product code EJL: Bur, Dental
EJL is the FDA product code for bur, dental. It is a Class I device, regulated under 21 CFR 872.3240 and reviewed by the Dental panel. FDA has cleared 27 510(k) submissions under EJL, from 25 different applicants. The average 510(k) review took 87 days (median 39). FDA has posted 13 recalls for EJL devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bur, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.3240 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EJL clearance
Top EJL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Almore Intl., Inc. | 2 | 1986-03-25 |
| Swiss American Metal Craft Corp. | 2 | 1980-12-30 |
| S.S. White Burs, Inc. | 1 | 2008-06-20 |
| Gebr. Brasseler GmbH & Co. KG | 1 | 2007-06-29 |
| B.T.I. Biotechnology Institute, Sl. | 1 | 2006-08-03 |
20 more applicants have EJL clearances. See the full list in Caduvo.
Most recent EJL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080687 | S.S. White Burs, Inc. | SMARTBURS | 2008-06-20 | 101 |
| K071352 | Gebr. Brasseler GmbH & Co. KG | CERADRILL | 2007-06-29 | 45 |
| K061383 | B.T.I. Biotechnology Institute, Sl. | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | 2006-08-03 | 77 |
| K943273 | Tri Hawk Corp. | TRI HAWK BUR, FG BUR | 1994-08-01 | 25 |
| K926205 | Utensili Super Abrasivi | MONOSTERYL | 1994-02-10 | 428 |
Recalls for EJL devices
13 product recalls in 9 recall events; 2 initiated in the last five years and 8 still open. Most recent: 2025-02-27.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 6 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code EJL?
EJL is the FDA product code for bur, dental. It is a Class I device, regulated under 21 CFR 872.3240 and reviewed by the Dental panel.
What device class is EJL?
Class I, regulation 21 CFR 872.3240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EJL?
Across 27 cleared submissions the average was 87 days from receipt to decision (median 39).
Which companies have the most EJL clearances?
Almore Intl., Inc. (2); Swiss American Metal Craft Corp. (2); S.S. White Burs, Inc. (1); Gebr. Brasseler GmbH & Co. KG (1); B.T.I. Biotechnology Institute, Sl. (1).
Have EJL devices been recalled?
Yes: 13 product recalls across 9 recall events; the most recent began 2025-02-27.
Next steps
- Run an FDA pathway report with predicate devices for product code EJL
- Run a recall and safety report across every EJL manufacturer
- Watch product code EJL 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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