Cleared Traditional

K211415 - GR Splint Resin System

K211415 · Pro3dure Medical GmbH · Dental device
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Optimized for regulatory review, auditing and printing
Oct 2021
Decision
168d
Days
-
Risk

K211415 is an FDA 510(k) clearance for the GR Splint Resin System. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Pro3dure Medical GmbH (Iserlohn, DE). The FDA issued a Cleared decision on October 21, 2021 after a review of 168 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 - K211415

510(k) Number K211415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2021
Decision Date October 21, 2021
Days to Decision 168 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
41d slower than avg
Panel avg: 127d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Regulatory and Quality Solutions, LLC
Patricia Kontoudis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQC Mouthguard, Prescription

All 42
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