FDA product code · Dental · Class 2
PLV: Dental Stereotaxic Instrument
PLV is FDA's product code for "Dental Stereotaxic Instrument": a Class 2 device classified under 21 CFR 872.4120, reviewed by the Dental panel.
510(k) review time for PLV
Across 20 510(k) clearances under PLV decided from 2018-01-01 to 2026-10-06, the median was 116 days from FDA receipt to decision. Half took between 86 and 134 days, and 80% were decided within 162 days. These are past clearances, not a forecast for a new submission.
| Fastest | 26 |
|---|---|
| 25th percentile | 86 |
| Median | 116 |
| 75th percentile | 134 |
| 80th percentile | 162 |
| 90th percentile | 298 |
| Slowest | 454 |
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.
FDA-recognized standards that cite PLV
1 FDA recognized consensus standard cite PLV, among them ISO 8325 Third edition 2023-03. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-317 ISO 8325 Third edition 2023-03 — Dentistry - Test methods for rotary instruments
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.