Cleared Traditional

K231775 - GR Resin System MSI (FDA 510(k) Clearance)

K231775 · Pro3Dure Medical · Dental device

Aug 2024

Decision

419d

Days

Risk

K231775 is an FDA 510(k) clearance for the GR Resin System MSI. This device is classified as a Mouthguard, Prescription.

Submitted by Pro3Dure Medical (Iserlohn, DE). The FDA issued a Cleared decision on August 8, 2024, 419 days after receiving the submission on June 16, 2023.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K231775 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 16, 2023
Decision Date	August 08, 2024
Days to Decision	419 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF