Cleared Traditional

K201173 - E-Guard (FDA 510(k) Clearance)

K201173 · Envisiontec GmbH · Dental device

Nov 2020

Decision

210d

Days

Risk

K201173 is an FDA 510(k) clearance for the E-Guard. This device is classified as a Mouthguard, Prescription.

Submitted by Envisiontec GmbH (Gladbeck, DE). The FDA issued a Cleared decision on November 27, 2020, 210 days after receiving the submission on May 1, 2020.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K201173 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 01, 2020
Decision Date	November 27, 2020
Days to Decision	210 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF