510(k) K202465
K202465 is an FDA 510(k) premarket notification submitted by 3D Diagnostix, Inc. for the device "Night Guard". The FDA issued a decision of Substantially Equivalent on Nov 25, 2020. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. 3D Diagnostix, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 25, 2020
- Date Received
- Aug 27, 2020
- 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)