FDA product code · Dental · Class 2
OAT: Implant, Endosseous, Orthodontic
OAT is FDA's product code for "Implant, Endosseous, Orthodontic": a Class 2 device classified under 21 CFR 872.3640, reviewed by the Dental panel. FDA flags it as an implant.
510(k) review time for OAT
Across 17 510(k) clearances under OAT decided from 2018-01-01 to 2026-10-06, the median was 289 days from FDA receipt to decision. Half took between 224 and 391 days, and 80% were decided within 453 days. These are past clearances, not a forecast for a new submission.
| Fastest | 109 |
|---|---|
| 25th percentile | 224 |
| Median | 289 |
| 75th percentile | 391 |
| 80th percentile | 453 |
| 90th percentile | 534 |
| Slowest | 795 |
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.
OAT in the public FDA record
| 510(k) clearances, all years | 52 |
|---|---|
| GUDID device identifiers | 1,817 |
Counts of records, not of devices or events. Adverse event reports for OAT 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 OAT
1 FDA recognized consensus standard cite OAT, among them ISO 19023 First edition 2018-02. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-266 ISO 19023 First edition 2018-02 — Dentistry - Orthodontic anchor screws
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.