510(k) K210940
K210940 is an FDA 510(k) premarket notification submitted by Dmg Digital Enterprises SE for the device "LuxaPrint Ortho Plus". The FDA issued a decision of Substantially Equivalent on Sep 3, 2021. The device falls under product code MQC (Mouthguard, Prescription), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 3, 2021
- Date Received
- Mar 29, 2021
- 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)