FDA product code ELE: Implant, Subperiosteal
ELE is the FDA product code for implant, subperiosteal. It is a Class II device, regulated under 21 CFR 872.3645 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under ELE, 1 in the last five years, from 4 different applicants. The average 510(k) review took 161 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Implant, Subperiosteal |
| Device class | Class II |
| Regulation | 21 CFR 872.3645 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for ELE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 526 |
Compare with all 510(k) review times · Search every ELE clearance
Top ELE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| KLS-Martin L.P. | 1 | 2022-07-08 |
| Jeneric Ind. | 1 | 1986-08-29 |
| Katecho, Inc. | 1 | 1984-11-30 |
| Colmed, Ltd. | 1 | 1980-05-28 |
Most recent ELE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210228 | KLS-Martin L.P. | KLS Martin IPS Preprosthetic | 2022-07-08 | 526 |
| K862926 | Jeneric Ind. | SURGICAL VITEX | 1986-08-29 | 28 |
| K843557 | Katecho, Inc. | K-APATITE 20-40 MESH K-APATITE 40-60 | 1984-11-30 | 81 |
| K801208 | Colmed, Ltd. | HOLLOW BASKET TITANIUM DENTAL IMPLANT | 1980-05-28 | 8 |
Recalls for ELE devices
openFDA lists no recalls for product code ELE.
Frequently asked questions
What is FDA product code ELE?
ELE is the FDA product code for implant, subperiosteal. It is a Class II device, regulated under 21 CFR 872.3645 and reviewed by the Dental panel.
What device class is ELE?
Class II, regulation 21 CFR 872.3645. Typical premarket route: 510(k).
How long does a 510(k) take for product code ELE?
Across 4 cleared submissions the average was 161 days from receipt to decision (median 54).
Which companies have the most ELE clearances?
KLS-Martin L.P. (1); Jeneric Ind. (1); Katecho, Inc. (1); Colmed, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ELE
- Run a recall and safety report across every ELE manufacturer
- Watch product code ELE 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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