FDA product code · Dental · Class 2
PEM: Dental Barriers And Sleeves
PEM is FDA's product code for "Dental Barriers And Sleeves": a Class 2 device classified under 21 CFR 878.4370, reviewed by the Dental panel.
510(k) review time for PEM
Across 13 510(k) clearances under PEM decided from 2018-01-01 to 2026-10-06, the median was 106 days from FDA receipt to decision. Half took between 89 and 148 days, and 80% were decided within 174 days. These are past clearances, not a forecast for a new submission.
| Fastest | 63 |
|---|---|
| 25th percentile | 89 |
| Median | 106 |
| 75th percentile | 148 |
| 80th percentile | 174 |
| 90th percentile | 194 |
| Slowest | 203 |
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.
PEM in the public FDA record
| GUDID device identifiers | 795 |
|---|
Counts of records, not of devices or events. Adverse event reports for PEM 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 PEM
No FDA recognized consensus standard cites PEM 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.