SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
FDA 510(k) K212706 · Splintek, Inc.
510(k) numberK212706
Submission
- Device name
- SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
- Applicant
- Splintek, Inc.
Lenexa, KS, US - Received
- August 26, 2021
- Decision date
- December 13, 2021
- 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 |
| 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 |
| 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 |
|---|---|---|
| K250122 | SleepRight Snore AidLRK · Traditional | 05/19/2025SE |
| K212767 | SleepRight Select-Comfort Dental GuardMQC · Traditional | 12/22/2021SE |
| K193577 | SleepRight ProRx Custom Dental GuardOBR · Traditional | 06/01/2020SE |
| K172223 | SleepRight ProRx Custom Dental GuardOBR · Traditional | 11/17/2017SE |
Questions and answers
When was SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard cleared by the FDA?
SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (K212706) received a 510(k) decision of Substantially Equivalent on December 13, 2021, 109 days after the submission was received.
What is the product code of K212706?
The FDA product code is OBR – Mouthguard, Over-The-Counter, a Unclassified device.