Cleared Traditional

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

K211415 · Pro3dure Medical GmbH · Dental device

Oct 2021

Decision

168d

Days

Risk

K211415 is an FDA 510(k) clearance for the GR Splint Resin System. This device is classified as a Mouthguard, Prescription.

Submitted by Pro3dure Medical GmbH (Iserlohn, DE). The FDA issued a Cleared decision on October 21, 2021, 168 days after receiving the submission on May 6, 2021.

This device falls under the Dental FDA review panel.

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