Cleared Traditional

K220894 - SmileGuard (FDA 510(k) Clearance)

K220894 · Envisiontec GmbH · Dental device

Jun 2022

Decision

74d

Days

Risk

K220894 is an FDA 510(k) clearance for the SmileGuard. This device is classified as a Mouthguard, Prescription.

Submitted by Envisiontec GmbH (Gladbeck, DE). The FDA issued a Cleared decision on June 10, 2022, 74 days after receiving the submission on March 28, 2022.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K220894 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 2022
Decision Date	June 10, 2022
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF