Product code ELC: 510(k) clearances and predicates
Product code ELC covers Varios Combi Pro2. FDA lists 195 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
195 clearances on file under product code ELC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 4 |
| 2025 | 2 |
| 2026 so far | 2 |
Recent clearances
Newest ELC clearances in the FDA index, with applicant and decision date:
- K260773, Varios Combi Pro2, applicant Nakanishi, Inc., decided 2026-03-10. FDA record
- K253254, GBT Machine Airflow Prophylaxis Master, applicant E.M.S Electro Medical Systems S.A, decided 2026-01-28. FDA record
- K251689, VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11), applicant Nakanishi, Inc., decided 2025-09-19. FDA record
- K242317, Integrated Endo System (Meet Endo-II), applicant Denjoy Dental Co., Ltd., decided 2025-02-13. FDA record
- K233844, OdneClean, applicant Odne AG, decided 2024-08-08. FDA record
- K240707, Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017), applicant Shenzhen Micro Electric Intelligence Co., Ltd., decided 2024-07-02. FDA record
- K240801, BioSonic US200 Ultrasonic Scaler (60034537), applicant Dent4you AG, decided 2024-07-01. FDA record
- K233922, SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG, applicant Satelec - Acteon Group, decided 2024-03-11. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include GBT Machine Airflow Prophylaxis Master, VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11). Watch new ELC clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code ELC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent ELC clearances include Varios Combi Pro2.
How many 510(k) clearances use product code ELC?
195 at the time this page was generated, from openFDA records.
How do I find a predicate device under ELC?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new ELC clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.