Mouth Guard (ATG0603R)
FDA 510(k) K231865 · Reazeal Corp
510(k) numberK231865
Submission
- Device name
- Mouth Guard (ATG0603R)
- Applicant
- Reazeal Corp
Wilmington, DE, US - Received
- June 26, 2023
- Decision date
- November 6, 2023
- 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.
Other 510(k)s with product code OBR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260790 | G-Series Grind GuardOBR · Traditional | ASESSO HEALTH, Inc. | 06/25/2026SE |
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore…OBR · Traditional | 1987 Media Limited | 04/10/2026SE |
| K253641 | Owl Night GuardOBR · Traditional | Owl Dental Lab, Inc. | 02/26/2026SE |
| K252004 | enCore Night GuardOBR · Traditional | Encore Guards | 11/25/2025SE |
| K251778 | Remi Custom Night GuardOBR · Traditional | Remi | 10/17/2025SE |
| 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 |
| K221369 | FBCC Night GuardOBR · Traditional | Fbcc, Inc. | 11/18/2022SE |
| K222424 | Protect-It Custom Fit Dental GuardOBR · Traditional | Doc Brands, Inc. | 10/07/2022SE |
Questions and answers
When was Mouth Guard (ATG0603R) cleared by the FDA?
Mouth Guard (ATG0603R) (K231865) received a 510(k) decision of Substantially Equivalent on November 6, 2023, 133 days after the submission was received.
What is the product code of K231865?
The FDA product code is OBR – Mouthguard, Over-The-Counter, a Unclassified device.