Cleared Traditional

K182820 - The POD (FDA 510(k) Clearance)

K182820 · Advanced Facialdontics, LLC · Dental device
Jul 2019
Decision
286d
Days
-
Risk

K182820 is an FDA 510(k) clearance for the The POD. This device is classified as a Mouthguard, Prescription.

Submitted by Advanced Facialdontics, LLC (St James, US). The FDA issued a Cleared decision on July 17, 2019, 286 days after receiving the submission on October 4, 2018.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K182820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2018
Decision Date July 17, 2019
Days to Decision 286 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQC - Mouthguard, Prescription
Device Class -