FDA product code ELC: Scaler, Ultrasonic
ELC is the FDA product code for scaler, ultrasonic. It is a Class II device, regulated under 21 CFR 872.4850 and reviewed by the Dental panel. FDA has cleared 195 510(k) submissions under ELC, 15 in the last five years, from 102 different applicants. The average 510(k) review took 138 days (median 90); 116 days on average over the last three years. FDA has posted 10 recalls for ELC devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Scaler, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 872.4850 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ELC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 350 |
| 2018 | 1 | 323 |
| 2019 | 4 | 179 |
| 2020 | 1 | 200 |
| 2021 | 3 | 216 |
| 2022 | 2 | 292 |
| 2023 | 5 | 238 |
| 2024 | 4 | 136 |
| 2025 | 2 | 150 |
| 2026 | 2 | 61 |
Compare with all 510(k) review times · Search every ELC clearance
Top ELC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Intl. | 12 | 2005-09-02 |
| E.M.S Electro Medical Systems S.A | 10 | 2026-01-28 |
| Nakanishi, Inc. | 7 | 2026-03-10 |
| Satelec - Acteon Group | 7 | 2024-03-11 |
| Sonendo, Inc. | 7 | 2021-02-05 |
97 more applicants have ELC clearances. See the full list in Caduvo.
Most recent ELC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260773 | Nakanishi, Inc. | Varios Combi Pro2 | 2026-03-10 | 1 |
| K253254 | E.M.S Electro Medical Systems S.A | GBT Machine Airflow Prophylaxis Master | 2026-01-28 | 121 |
| K251689 | Nakanishi, Inc. | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | 2025-09-19 | 109 |
| K242317 | Denjoy Dental Co., Ltd. | Integrated Endo System (Meet Endo-II) | 2025-02-13 | 192 |
| K233844 | Odne AG | OdneClean | 2024-08-08 | 248 |
Recalls for ELC devices
10 product recalls in 5 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2024-05-30.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 2 |
| 2024 | 5 |
Frequently asked questions
What is FDA product code ELC?
ELC is the FDA product code for scaler, ultrasonic. It is a Class II device, regulated under 21 CFR 872.4850 and reviewed by the Dental panel.
What device class is ELC?
Class II, regulation 21 CFR 872.4850. Typical premarket route: 510(k).
How long does a 510(k) take for product code ELC?
Across 195 cleared submissions the average was 138 days from receipt to decision (median 90).
Which companies have the most ELC clearances?
Dentsply Intl. (12); E.M.S Electro Medical Systems S.A (10); Nakanishi, Inc. (7); Satelec - Acteon Group (7); Sonendo, Inc. (7).
Have ELC devices been recalled?
Yes: 10 product recalls across 5 recall events; the most recent began 2024-05-30.
Next steps
- Run an FDA pathway report with predicate devices for product code ELC
- Run a recall and safety report across every ELC manufacturer
- Watch product code ELC 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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