510(k) K220894
K220894 is an FDA 510(k) premarket notification submitted by Envisiontec GmbH for the device "SmileGuard". The FDA issued a decision of Substantially Equivalent on June 10, 2022. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Envisiontec GmbH has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2022
- Date Received
- March 28, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type