Cleared Traditional

K212017 - Thermeo System

K212017 · Pro3dure Medical GmbH · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K212017

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.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 42
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K212017.
Dental LT Clear V2 Resin
K222061 · Formlabs Ohio, Inc. · Nov 2022
NextDent Ortho Flex
K221022 · Vertex-Dental B.V. · Oct 2022
SmileGuard
K220894 · Envisiontec GmbH · Jun 2022
Glidewell Appliance Resin, Hard/Soft
K214102 · Prismatik Dentalcraft, Inc. · Feb 2022
SleepRight Select-Comfort Dental Guard
K212767 · Splintek, Inc. · Dec 2021
NightGuard Flex
K212448 · Sprintray, Inc. · Nov 2021