510(k) K182820
K182820 is an FDA 510(k) premarket notification submitted by Advanced Facialdontics, LLC for the device "The POD". The FDA issued a decision of Substantially Equivalent on Jul 17, 2019. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Advanced Facialdontics, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 17, 2019
- Date Received
- Oct 4, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Review Panel
- DE
- Submission Type
- 510(k)