Cleared Traditional

GR Splint Resin System (K211415) - FDA 510(k) Clearance

K211415 · Pro3dure Medical GmbH · Dental device
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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

Submission Details

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.

Device Classification

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 40
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