FDA product code · Dental · Class 2
PNN: Orthodontic Software
PNN is FDA's product code for "Orthodontic Software": a Class 2 device classified under 21 CFR 872.5470, reviewed by the Dental panel.
510(k) review time for PNN
Across 32 510(k) clearances under PNN decided from 2018-01-01 to 2026-10-06, the median was 160 days from FDA receipt to decision. Half took between 90 and 215 days, and 80% were decided within 227 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 90 |
| Median | 160 |
| 75th percentile | 215 |
| 80th percentile | 227 |
| 90th percentile | 255 |
| Slowest | 295 |
| Year | Median days | n |
|---|---|---|
| 2018 | 229 | 5 |
| 2020 | 221 | 7 |
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.
PNN in the public FDA record
| 510(k) clearances, all years | 34 |
|---|
Counts of records, not of devices or events. Adverse event reports for PNN 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 PNN
No FDA recognized consensus standard cites PNN by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.