K212017 - Thermeo System (FDA 510(k) Clearance)

K212017 is an FDA 510(k) clearance for the Thermeo System. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Pro3dure Medical GmbH (Iserlohn, DE). The FDA issued a Cleared decision on April 8, 2022 after a review of 284 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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