Cleared Traditional

K210011 - JS Dental Lab Mouth Guard (FDA 510(k) Clearance)

K210011 · Ampower Dental Laboratories, LLC · Dental device

Jul 2021

Decision

193d

Days

Risk

K210011 is an FDA 510(k) clearance for the JS Dental Lab Mouth Guard. This device is classified as a Mouthguard, Prescription.

Submitted by Ampower Dental Laboratories, LLC (Hayward, US). The FDA issued a Cleared decision on July 16, 2021, 193 days after receiving the submission on January 4, 2021.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K210011 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 04, 2021
Decision Date	July 16, 2021
Days to Decision	193 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF