The following data is part of a premarket notification filed by Ampower Dental Laboratories, Llc with the FDA for Js Dental Lab Mouth Guard.
| Device ID | K210011 |
| 510k Number | K210011 |
| Device Name: | JS Dental Lab Mouth Guard |
| Classification | Mouthguard, Prescription |
| Applicant | Ampower Dental Laboratories, LLC 3423 Investment Blvd Suite 11 Hayward Hayward, CA 94545 |
| Contact | Dylan Hao |
| Correspondent | Parul Chansoria Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, WY 82801 |
| 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 | 2021-01-04 |
| Decision Date | 2021-07-16 |