Cleared Traditional

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

K212017 · Pro3dure Medical GmbH · Dental device

Apr 2022

Decision

284d

Days

Risk

K212017 is an FDA 510(k) clearance for the Thermeo System. This device is classified as a Mouthguard, Prescription.

Submitted by Pro3dure Medical GmbH (Iserlohn, DE). The FDA issued a Cleared decision on April 8, 2022, 284 days after receiving the submission on June 28, 2021.

This device falls under the Dental FDA review panel.

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