510(k) K260031
K260031 is an FDA 510(k) premarket notification submitted by Pro3Dure Medical GmbH for the device "THERMEO® I MSI". The FDA issued a decision of Substantially Equivalent on Sep 29, 2026. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. Pro3Dure Medical GmbH has 5 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 2026
- Date Received
- Jan 6, 2026
- 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)