FDA product code · Dental · Class 2
ELC: Scaler, Ultrasonic
ELC is FDA's product code for "Scaler, Ultrasonic": a Class 2 device classified under 21 CFR 872.4850, reviewed by the Dental panel.
510(k) review time for ELC
Across 24 510(k) clearances under ELC decided from 2018-01-01 to 2026-10-06, the median was 198 days from FDA receipt to decision. Half took between 106 and 270 days, and 80% were decided within 287 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 106 |
| Median | 198 |
| 75th percentile | 270 |
| 80th percentile | 287 |
| 90th percentile | 322 |
| Slowest | 405 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
ELC in the public FDA record
| 510(k) clearances, all years | 195 |
|---|---|
| Device recalls | 10 |
| Establishment listings | 267 |
| GUDID device identifiers | 3,779 |
Counts of records, not of devices or events. Adverse event reports for ELC are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite ELC
4 FDA recognized consensus standards cite ELC, among them ISO 7405 Third edition 2018-10 Corrected version 2018-12; IEC 80601-2-60 Edition 2.0 2019-06; ISO 18397 First edition 2016-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12 — Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- 4-262 IEC 80601-2-60 Edition 2.0 2019-06 — Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- 4-336 ISO 18397 First edition 2016-01 — Dentistry - Powered scaler
- 4-355 ISO 18397 Second edition 2025-07 — Dentistry - Powered scaler
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.