FDA product code · Dental
ELCScaler, Ultrasonic
Product code ELC covers Scaler, Ultrasonic, a Class II device regulated under 21 CFR 872.4850. FDA has cleared 195 devices in this code, 3 of them in the last 12 months. Median review time across the 195 most recent decisions is 90 days. openFDA lists 10 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.4850
- Review panel
- Dental
- Clearances
- 195
What is happening in ELC right now?
ELC (Scaler, Ultrasonic): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in ELC?
FDA has cleared 195 devices under product code ELC since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260773 | Varios Combi Pro2 | Nakanishi, Inc. | |
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | |
| K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | |
| K233844 | OdneClean | Odne AG | |
| 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) | Shenzhen Micro Electric Intelligence Co., Ltd. | |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | |
| 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 | Satelec - Acteon Group | |
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. |
How long does FDA review take for ELC?
The median FDA review time for ELC is 90 days, measured across the 195 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in ELC?
openFDA lists 10 recall records against product code ELC. A recall record covers one firm's corrective action and may span many device lots.
Z-2177-2024Open, ClassifiedDental EZ Group Star Dental Division
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Z-2178-2024Open, ClassifiedDental EZ Group Star Dental Division
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Z-1686-2024Open, ClassifiedElectro Medical Systems SA
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Z-1687-2024Open, ClassifiedElectro Medical Systems SA
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Z-1688-2024Open, ClassifiedElectro Medical Systems SA
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Showing the 5 most recently initiated of 10. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for ELC?
MAUDE holds 744 adverse-event reports naming product code ELC, 204 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in ELC unusual?
One month sits above ELC's own expected range: 1 April 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 22 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 22 | 8–27 | Within expected (8–27) | |
| 10 | 8–25 | Within expected (8–25) | |
| 10 | 6–26 | Within expected (6–26) | |
| 34 | 4–26 | Above expected (4–26) | |
| 28 | 6–33 | Within expected (6–33) | |
| 33 | 8–38 | Within expected (8–38) | |
| 21 | 14–67 | Within expected (14–67) | |
| 27 | 6–46 | Within expected (6–46) | |
| 22 | 8–48 | Within expected (8–48) | |
| 32 | 6–46 | Within expected (6–46) | |
| 11 | 7–43 | Within expected (7–43) | |
| 29 | 2–44 | Within expected (2–44) | |
| 28 | 4–53 | Within expected (4–53) | |
| 24 | 3–45 | Within expected (3–45) | |
| 35 | 5–47 | Within expected (5–47) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in ELC.
What are the predicate devices in ELC?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in ELC?
Across the 195 most recent decisions, these applicants filed most often in ELC.
| Applicant | Recent clearances |
|---|---|
| Dentsply Intl. | 12 |
| E.M.S Electro Medical Systems S.A | 10 |
| Bonart Co., Ltd. | 7 |
| Litton Dental Products | 7 |
| Nakanishi, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in ELC files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Dentsply Intl., Inc. | 13 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch ELC
Get an email the morning anything changes in ELC — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Dental
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.