FDA product code · Dental · Class U
OBR: Mouthguard, Over-The-Counter
OBR is FDA's product code for "Mouthguard, Over-The-Counter": a Class U device, reviewed by the Dental panel.
510(k) review time for OBR
Across 22 510(k) clearances under OBR decided from 2018-01-01 to 2026-10-06, the median was 142 days from FDA receipt to decision. Half took between 101 and 183 days, and 80% were decided within 235 days. These are past clearances, not a forecast for a new submission.
| Fastest | 54 |
|---|---|
| 25th percentile | 101 |
| Median | 142 |
| 75th percentile | 183 |
| 80th percentile | 235 |
| 90th percentile | 266 |
| Slowest | 639 |
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.
OBR in the public FDA record
| 510(k) clearances, all years | 46 |
|---|
Counts of records, not of devices or events. Adverse event reports for OBR 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 OBR
3 FDA recognized consensus standards cite OBR, among them ISO 20795-2 Second edition 2013-03-01; ANSI ADA Standard No. 99-2001 (R2023); ANSI ADA Standard No. 139-2020. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-233 ISO 20795-2 Second edition 2013-03-01 — Dentistry - Base polymers - Part 2: Orthodontic base polymers
- 4-254 ANSI ADA Standard No. 99-2001 (R2023) — Athletic Mouth Protectors and Materials
- 4-294 ANSI ADA Standard No. 139-2020 — Dental Base Polymers
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.