510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212017Substantially Equivalent

Thermeo System

PRO3DURE Medical GmbH, Iserlohn, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212017 is the FDA 510(k) clearance record for Thermeo System, cleared for Pro3Dure Medical GmbH on under FDA product code MQC (Mouthguard, Prescription). FDA records list 5 510(k) clearances for Pro3Dure Medical GmbH, from to . As of , FDA records show no recalls naming K212017.

Clearance record

Decision date
Received
(284 days to decision)
Product code
MQC Mouthguard, Prescription
Device class
Unclassified
Review panel
Unknown
Applicant
Pro3Dure Medical GmbH Am Burgberg 13, Iserlohn, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQC

Trailing 12 months
2 clearances under product code MQC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MQC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260