510(k) clearance
THERMEO® I MSI
- 510(k) number
- K260031
- Applicant
- Pro3Dure Medical GmbH
- Decision date
- Sep 29, 2026
- Date received
- Jan 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- MQC
- Device type
- Mouthguard, Prescription
- Device class
- Unclassified
- Advisory committee
- Unknown
- Statement or summary
- Summary
- Third party
- N
- Location
- Iserlohn, DE