NightGuard Flex
Mouthguard, Prescription
SprintRay Inc
The following data is part of a premarket notification filed by Sprintray Inc with the FDA for Nightguard Flex.
Pre-market Notification Details
| Device ID | K212448 |
| 510k Number | K212448 |
| Device Name: | NightGuard Flex |
| Classification | Mouthguard, Prescription |
| Applicant | SprintRay Inc 2705 Media Center Drive, Suite 100A Los Angeles, CA 90065 |
| Contact | Sara Moghtadernejad |
| Correspondent | Sara Moghtadernejad SprintRay Inc 2705 Media Center Drive, Suite 100A Los Angeles, CA 90065 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-05 |
| Decision Date | 2021-11-12 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850039704069 | K212448 | 000 |
Trademark Results [NightGuard Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIGHTGUARD FLEX 90805150 not registered Live/Pending |
SprintRay Inc 2021-06-30 |
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