Submission Details
| 510(k) Number | K240810 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2024 |
| Decision Date | May 24, 2024 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
Anti Grinding Guard
May 2024
Decision
60d
Days
—
Risk
About This 510(k) Submission
K240810 is an FDA 510(k) clearance for the Anti Grinding Guard, a Mouthguard, Over-the-counter, submitted by Xiamen Yizhou Imp. & Exp. Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on May 24, 2024, 60 days after receiving the submission on March 25, 2024. This device falls under the Dental review panel.
Device Classification
| Product Code | OBR — Mouthguard, Over-the-counter |
| Device Class | — |
| Definition | To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding. |
Manufacturer
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