Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
ELC — Predicate Candidate Screening
195 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
305 days90th percentile
195clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260773 | Varios Combi Pro2 | Nakanishi, Inc. | 2026-03-10 | 1 | 0 |
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | 2026-01-28 | 121 | 0 |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX S | Nakanishi, Inc. | 2025-09-19 | 109 | 0 |
| K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | 2025-02-13 | 192 | 0 |
| K233844 | OdneClean | Odne AG | 2024-08-08 | 248 | 0 |
| K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G0 | Shenzhen Micro Electric Intelligence Co., Ltd. | 2024-07-02 | 109 | 0 |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | 2024-07-01 | 98 | 0 |
| K233922 | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; | Satelec - Acteon Group | 2024-03-11 | 89 | 0 |
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | 2023-12-11 | 405 | 0 |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-21 | 258 | 0 |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | 2023-07-14 | 276 | 0 |
| K231391 | Combi Touch | Mectron S.P.A. | 2023-05-15 | 3 | 0 |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | 2023-03-23 | 248 | 0 |
| K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | Changzhou Bomedent Medical Technology Co.,Ltd | 2022-09-08 | 265 | 0 |
| K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | 2022-02-02 | 320 | 0 |
| K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-10 | 365 | 0 |
| K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021-04-13 | 196 | 0 |
| K203302 | GentleWave X | Sonendo, Inc. | 2021-02-05 | 88 | 0 |
| K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. | 2020-12-04 | 200 | 0 |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019-10-20 | 268 | 3 |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A | 2019-08-16 | 115 | 0 |
| K182145 | tün® ultrasonic tips product family | Engineered Endodontics | 2019-06-07 | 303 | 0 |
| K190359 | Sonendo GentleWave System | Sonendo, Inc. | 2019-03-16 | 29 | 2 |
| K171150 | AW-100 | Micron Corporation | 2018-03-08 | 323 | 0 |
| K170104 | COMPACT S, COMPACT S (LED) | Dmetec.Co., Ltd. | 2017-12-27 | 349 | 0 |
| K163414 | Ultrasonic scaler | Nanning VV Dental Co., Ltd. | 2017-11-21 | 351 | 0 |
| K161639 | Y-MIC | Micron Corporation | 2016-12-22 | 191 | 0 |
| K160905 | Sonendo GentleWave System | Sonendo, Inc. | 2016-06-03 | 63 | 0 |
| K153157 | Sonendo Gentle Wave System | Sonendo, Inc. | 2016-01-29 | 88 | 0 |
| K151023 | COMPACT PIEZO LED | Mectron S.P.A. | 2015-08-05 | 111 | 0 |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | 2015-06-16 | 105 | 0 |
| K143448 | Sonendo GentleWave System | Sonendo, Inc. | 2015-05-01 | 150 | 0 |
| K140233 | ULTRASONIC SCALER | Nanning Baolai Medical Instrument Co., Ltd. | 2015-04-06 | 431 | 0 |
| K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A | 2015-02-27 | 316 | 0 |
| K140965 | MULTIPIEZO PRO, MULTIPIEZO | Mectron S.P.A. | 2014-08-20 | 127 | 0 |
| K133752 | SONENDO OMNICLEAN ENDOTHERPAY SYSTEM CONSOLE, SONENDO OMNICL | Sonendo, Inc. | 2014-05-15 | 157 | 0 |
| K132322 | NEWTRON P5 XS B.LED | Satelec - Acteon Group | 2014-03-11 | 229 | 0 |
| K132267 | NEWTRON P5, NEWTRON P5 B.LED | Satelec - Acteon Group | 2014-03-10 | 231 | 0 |
| K132609 | EDS ULTRASONIC TIPS | Essential Dental Systems, Inc. | 2014-01-22 | 155 | 0 |
| K131151 | ENDOCENTER | Satelec - Acteon Group | 2014-01-16 | 268 | 0 |
| K132445 | PIEZON 250 | E.M.S Electro Medical Systems S.A | 2013-12-06 | 122 | 0 |
| K131997 | NEWTRON BOOSTER | Satelec - Acteon Group | 2013-11-26 | 151 | 0 |
| K132443 | PIEZON 150 | E.M.S Electro Medical Systems S.A | 2013-11-22 | 108 | 0 |
| K130834 | R7 | Cefla S.C. | 2013-10-08 | 196 | 0 |
| K130137 | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER | Coltene/Whaledent | 2013-08-23 | 217 | 0 |
| K130693 | AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM | Aseptico, Inc. | 2013-08-14 | 153 | 0 |
| K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | Dentsply Intl., Inc. | 2013-07-23 | 117 | 0 |
| K122748 | ENGLER 25K SERIES ULTRASONIC INSERTS | Engler Engineering Corp. | 2013-06-11 | 277 | 0 |
| K130025 | SONENDO ENDOTHERAPY SYSTEM | Sonendo, Inc. | 2013-06-11 | 159 | 0 |
| K122501 | AEI DR. TERAUCHI ULTRASONIC TIPS | American Eagle Instruments, Inc. | 2013-03-29 | 225 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda