FDA product code EMJ: Elevator, Surgical, Dental
EMJ is the FDA product code for elevator, surgical, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 6 510(k) submissions under EMJ, from 5 different applicants. The average 510(k) review took 36 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Elevator, Surgical, Dental |
| 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 EMJ clearance
Top EMJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 2 | 1985-06-14 |
| Military Engineering, Inc. | 1 | 1987-04-03 |
| Ipco Corp. | 1 | 1985-04-12 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
| Depuy, Inc. | 1 | 1977-09-28 |
Most recent EMJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870589 | Military Engineering, Inc. | ELEVATOR, ROOT, SINGLE-ENDED | 1987-04-03 | 52 |
| K851717 | Artiberia | 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR | 1985-06-14 | 50 |
| K851713 | Artiberia | 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA | 1985-06-11 | 47 |
| K850906 | Ipco Corp. | TACTILE PLUS DENTAL ELEVATORS | 1985-04-12 | 38 |
| K821788 | Pacific Dental Corp. | BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT | 1982-07-06 | 19 |
Recalls for EMJ devices
openFDA lists no recalls for product code EMJ.
Frequently asked questions
What is FDA product code EMJ?
EMJ is the FDA product code for elevator, surgical, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMJ?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMJ?
Across 6 cleared submissions the average was 36 days from receipt to decision (median 42).
Which companies have the most EMJ clearances?
Artiberia (2); Military Engineering, Inc. (1); Ipco Corp. (1); Pacific Dental Corp. (1); Depuy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMJ
- Run a recall and safety report across every EMJ manufacturer
- Watch product code EMJ 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times