FDA product code EMI: File, Bone, Surgical
EMI is the FDA product code for file, bone, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under EMI, from 4 different applicants. The average 510(k) review took 73 days (median 43). FDA has posted 4 recalls for EMI devices.
Classification
| Field | Value |
|---|---|
| Device name | File, Bone, Surgical |
| 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 EMI clearance
Top EMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomedical Composites, Ltd. | 1 | 1992-03-02 |
| Wilde-USA, Inc. | 1 | 1991-08-16 |
| Artiberia | 1 | 1985-06-11 |
| Today'S Machining & Design, Inc. | 1 | 1983-01-09 |
Most recent EMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K914035 | Biomedical Composites, Ltd. | MINI-MILL | 1992-03-02 | 174 |
| K912989 | Wilde-USA, Inc. | PLANUSTAR AND DENS NOBILIS DENTURE TEETH | 1991-08-16 | 39 |
| K851716 | Artiberia | 865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES | 1985-06-11 | 47 |
| K823676 | Today'S Machining & Design, Inc. | DISC NEEDLE SET #TX-8220 | 1983-01-09 | 33 |
Recalls for EMI devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-04-26.
| Year | Recalls |
|---|---|
| 2021 | 4 |
Frequently asked questions
What is FDA product code EMI?
EMI is the FDA product code for file, bone, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMI?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMI?
Across 4 cleared submissions the average was 73 days from receipt to decision (median 43).
Which companies have the most EMI clearances?
Biomedical Composites, Ltd. (1); Wilde-USA, Inc. (1); Artiberia (1); Today'S Machining & Design, Inc. (1).
Have EMI devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2021-04-26.
Next steps
- Run an FDA pathway report with predicate devices for product code EMI
- Run a recall and safety report across every EMI manufacturer
- Watch product code EMI 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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