THERMEO® I MSI— 510(k) K260031
Substantially EquivalentPro3Dure Medical GmbH
FDA 510(k) clearance K260031 for THERMEO® I MSI, Substantially Equivalent on 2026-09-29. Applicant: Pro3Dure Medical GmbH. Device class: Unclassified.
Summary
THERMEO I MSI is filed under MQC, prescription mouthguards. The record doesn't describe the material or design beyond the product name.
The device class is listed as U (unclassified), with no regulation number, and the advisory panel field reads Unknown. Pro3Dure Medical GmbH filed it as a Traditional 510(k).
Pro3Dure is in Iserlohn, Germany. Review took 266 days, from January 6 to September 29, 2026. That count is calendar days, not FDA review days.
Clearance details
- Applicant
- Pro3Dure Medical GmbH
- Product code
- Product code MQC
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Iserlohn, DE
Recent devices under product code MQC
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view allAdverse events under product code MQC
product code MQC- Injury
- 377
- Total
- 377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.