FDA product code · Dental · Class U
LQY: Locator, Root Apex
LQY is FDA's product code for "Locator, Root Apex": a Class U device, reviewed by the Dental panel.
510(k) review time for LQY
Across 11 510(k) clearances under LQY decided from 2018-01-01 to 2026-10-06, the median was 218 days from FDA receipt to decision. Half took between 117 and 252 days, and 80% were decided within 266 days. These are past clearances, not a forecast for a new submission.
| Fastest | 90 |
|---|---|
| 25th percentile | 117 |
| Median | 218 |
| 75th percentile | 252 |
| 80th percentile | 266 |
| 90th percentile | 281 |
| Slowest | 373 |
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.
LQY in the public FDA record
| 510(k) clearances, all years | 46 |
|---|
Counts of records, not of devices or events. Adverse event reports for LQY 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 LQY
1 FDA recognized consensus standard cite LQY, among them ISO 7405 Third edition 2018-10 Corrected version 2018-12. 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
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.