510(k) K221022
K221022 is an FDA 510(k) premarket notification submitted by Vertex-Dental B.V. for the device "NextDent Ortho Flex". The FDA issued a decision of Substantially Equivalent on Oct 21, 2022. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Vertex-Dental B.V. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 21, 2022
- Date Received
- Apr 6, 2022
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type