Cleared Traditional

The POD

K182820 · Advanced Facialdontics, LLC · Dental

Jul 2019

Decision

286d

Days

—

Risk

About This 510(k) Submission

K182820 is an FDA 510(k) clearance for the The POD, 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 review panel.

Submission Details

510(k) Number	K182820 FDA.gov
FDA Decision	Cleared 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