THE BITE GUARD
FDA 510(k) clearance K132469 · decided 2014-02-28
Clearance details
- K-number
- K132469
- Device name
- THE BITE GUARD
- Applicant
- International Profit Builders, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-07
- Decision date
- 2014-02-28
- Days to decision
- 205 days
- Clearance type
- Abbreviated
- Product code
- OBR
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Highland, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| G-Series Grind Guard (K260790) | ASESSO HEALTH, Inc. | 2026-06-25 |
| ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) (K252485) | 1987 Media Limited | 2026-04-10 |
| Owl Night Guard (K253641) | Owl Dental Lab, Inc. | 2026-02-26 |
| enCore Night Guard (K252004) | Encore Guards | 2025-11-25 |
| Remi Custom Night Guard (K251778) | Remi | 2025-10-17 |
| Dentemp Pro-Comfort Dental Guard (K250456) | Doc Brands, Inc. | 2025-05-19 |
| Anti Grinding Guard (K240810) | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 2024-05-24 |
| Goyo Mouthpiece S (K232238) | Dimedikorea | 2024-04-17 |
| Mouth Guard (ATG0603R) (K231865) | Reazeal Corp | 2023-11-06 |
| FBCC Night Guard (K221369) | Fbcc, Inc. | 2022-11-18 |
| Protect-It Custom Fit Dental Guard (K222424) | Doc Brands, Inc. | 2022-10-07 |
| SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (K212706) | Splintek, Inc. | 2021-12-13 |
Recalls involving this device
No recalls on record reference this clearance.