510(k) K212017
K212017 is an FDA 510(k) premarket notification submitted by Pro3Dure Medical GmbH for the device "Thermeo System". The FDA issued a decision of Substantially Equivalent on April 8, 2022. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Pro3Dure Medical GmbH has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2022
- Date Received
- June 28, 2021
- 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