Cleared Traditional

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

K212017 · Pro3dure Medical GmbH · Dental device
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
284d
Days
-
Risk

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.

View all Pro3dure Medical GmbH devices

Submission Details

510(k) Number K212017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2021
Decision Date April 08, 2022
Days to Decision 284 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 127d · This submission: 284d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
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