Brux Mouthguards
FDA 510(k) K111310 · Dental Arte, Inc.
510(k) numberK111310
Submission
- Device name
- Brux Mouthguards
- Applicant
- Dental Arte, Inc.
Braderdon, FL, US - Received
- May 10, 2011
- Decision date
- December 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBR – Mouthguard, Over-The-Counter
- Device class
- Unclassified
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
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|---|---|---|---|
| K260790 | G-Series Grind GuardOBR · Traditional | ASESSO HEALTH, Inc. | 06/25/2026SE |
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| K253641 | Owl Night GuardOBR · Traditional | Owl Dental Lab, Inc. | 02/26/2026SE |
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| K250456 | Dentemp Pro-Comfort Dental GuardOBR · Traditional | Doc Brands, Inc. | 05/19/2025SE |
| K240810 | Anti Grinding GuardOBR · Traditional | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 05/24/2024SE |
| K232238 | Goyo Mouthpiece SOBR · Traditional | Dimedikorea | 04/17/2024SE |
| K231865 | Mouth Guard (ATG0603R)OBR · Traditional | Reazeal Corp | 11/06/2023SE |
| K221369 | FBCC Night GuardOBR · Traditional | Fbcc, Inc. | 11/18/2022SE |
More from Fbcc, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060086 | Feniiiiiix Coloration KitEIH · Traditional | 03/03/2006SE |
Questions and answers
When was Brux Mouthguards cleared by the FDA?
Brux Mouthguards (K111310) received a 510(k) decision of Substantially Equivalent on December 8, 2011, 212 days after the submission was received.
What is the product code of K111310?
The FDA product code is OBR – Mouthguard, Over-The-Counter, a Unclassified device.