FDA product code · Dental · Class 1
EKX: Handpiece, Direct Drive, Ac-Powered
EKX is FDA's product code for "Handpiece, Direct Drive, Ac-Powered": a Class 1 device classified under 21 CFR 872.4200, reviewed by the Dental panel.
510(k) review time for EKX
Across 29 510(k) clearances under EKX decided from 2018-01-01 to 2026-10-06, the median was 266 days from FDA receipt to decision. Half took between 179 and 359 days, and 80% were decided within 409 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 179 |
| Median | 266 |
| 75th percentile | 359 |
| 80th percentile | 409 |
| 90th percentile | 481 |
| Slowest | 703 |
| Year | Median days | n |
|---|---|---|
| 2021 | 214 | 5 |
| 2025 | 244 | 5 |
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.
EKX in the public FDA record
| 510(k) clearances, all years | 89 |
|---|---|
| Establishment listings | 141 |
| GUDID device identifiers | 773 |
Counts of records, not of devices or events. Adverse event reports for EKX 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 EKX
9 FDA recognized consensus standards cite EKX, 3 of them recognized only in part, among them ISO 9168 Third edition 2009-07-15; IEC 80601-2-60 Edition 2.0 2019-06; ISO 3964 Third edition 11-2016. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-180 ISO 9168 Third edition 2009-07-15 — Dentistry - Hose connectors for air driven dental handpieces
- 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
- 4-269 ISO 3964 Third edition 11-2016 — Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
- 4-276 ISO 14457 Second edition 2017-10 (partial recognition) — Dentistry - Handpieces and motors
- 4-281 ISO 1797 Third Edition 2017-05 — Dentistry - Shanks for rotary and oscillating instruments
- 4-305 ISO 10637 Second edition 2018-05 (partial recognition) — Dentistry - Central suction source equipment
- 4-306 ISO 22052 First edition 2020-06 (partial recognition) — Dentistry - Compressed air source equipment
- 4-317 ISO 8325 Third edition 2023-03 — Dentistry - Test methods for rotary instruments
- 4-395 ISO 21850-1 First edition 2020-04 — Dentistry - Materials for dental instruments - Part 1: Stainless steel
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.