FDA product code EIL: Gauge, Depth, Instrument, Dental
EIL is the FDA product code for gauge, depth, instrument, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 8 510(k) submissions under EIL, from 7 different applicants. The average 510(k) review took 59 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Gauge, Depth, Instrument, 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 EIL clearance
Top EIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abiomed, Inc. | 2 | 1991-07-09 |
| Florida Probe Corp. | 1 | 1989-03-13 |
| Vine Valley Research | 1 | 1989-01-05 |
| Dentsply Intl. | 1 | 1988-04-27 |
| Bowen & Company, Inc. | 1 | 1987-07-31 |
2 more applicants have EIL clearances. See the full list in Caduvo.
Most recent EIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911643 | Abiomed, Inc. | ABIODENT PERIOTEMP(R) SYSTEM | 1991-07-09 | 88 |
| K890493 | Florida Probe Corp. | FLORIDA PROBE PERIODONTAL PROBE | 1989-03-13 | 41 |
| K885075 | Abiomed, Inc. | ABIOMED PERIOTEMP(TM) PROBE | 1989-02-13 | 67 |
| K884813 | Vine Valley Research | MODEL 200A ELECTRONIC FORCE-SENSING PROBE | 1989-01-05 | 49 |
| K880209 | Dentsply Intl. | PERIODONTAL PROBE - AUTOPROBE | 1988-04-27 | 103 |
Recalls for EIL devices
openFDA lists no recalls for product code EIL.
Frequently asked questions
What is FDA product code EIL?
EIL is the FDA product code for gauge, depth, instrument, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIL?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIL?
Across 8 cleared submissions the average was 59 days from receipt to decision (median 54).
Which companies have the most EIL clearances?
Abiomed, Inc. (2); Florida Probe Corp. (1); Vine Valley Research (1); Dentsply Intl. (1); Bowen & Company, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIL
- Run a recall and safety report across every EIL manufacturer
- Watch product code EIL 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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