FDA product code OBR: Mouthguard, Over-The-Counter
OBR is the FDA product code for mouthguard, over-the-counter. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 47 510(k) submissions under OBR, 12 in the last five years, from 32 different applicants. The average 510(k) review took 131 days (median 109); 137 days on average over the last three years.
Definition
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Classification
| Field | Value |
|---|---|
| Device name | Mouthguard, Over-The-Counter |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for OBR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 116 |
| 2018 | 2 | 155 |
| 2019 | 3 | 214 |
| 2020 | 3 | 294 |
| 2021 | 2 | 130 |
| 2022 | 2 | 124 |
| 2023 | 1 | 133 |
| 2024 | 2 | 162 |
| 2025 | 3 | 123 |
| 2026 | 4 | 126 |
Compare with all 510(k) review times · Search every OBR clearance
Top OBR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Den Tek Oral Care, Inc. | 6 | 2015-09-30 |
| Ranir, LLC | 6 | 2013-12-20 |
| Splintek, Inc. | 3 | 2021-12-13 |
| Doc Brands, Inc. | 2 | 2025-05-19 |
| Boyd Research, Inc. | 2 | 2021-09-17 |
27 more applicants have OBR clearances. See the full list in Caduvo.
Most recent OBR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262559 | ChangSha ChuangDuoLe E-Commerce Co., Ltd. | Mouth Guard | 2026-09-16 | 54 |
| K260790 | ASESSO HEALTH, Inc. | G-Series Grind Guard | 2026-06-25 | 106 |
| K252485 | 1987 Media Limited | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) | 2026-04-10 | 246 |
| K253641 | Owl Dental Lab, Inc. | Owl Night Guard | 2026-02-26 | 99 |
| K252004 | Encore Guards | enCore Night Guard | 2025-11-25 | 151 |
Recalls for OBR devices
openFDA lists no recalls for product code OBR.
Frequently asked questions
What is FDA product code OBR?
OBR is the FDA product code for mouthguard, over-the-counter. It is a Unclassified device, reviewed by the Dental panel.
What device class is OBR?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBR?
Across 47 cleared submissions the average was 131 days from receipt to decision (median 109).
Which companies have the most OBR clearances?
Den Tek Oral Care, Inc. (6); Ranir, LLC (6); Splintek, Inc. (3); Doc Brands, Inc. (2); Boyd Research, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OBR
- Run a recall and safety report across every OBR manufacturer
- Watch product code OBR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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