Cleared Traditional

GR Resin System MSI

K231775 · Pro3Dure Medical · Dental

Aug 2024

Decision

419d

Days

—

Risk

About This 510(k) Submission

K231775 is an FDA 510(k) clearance for the GR Resin System MSI, 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 review panel.

Submission Details

510(k) Number	K231775 FDA.gov
FDA Decision	Cleared 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