Cleared Traditional

K202465 - Night Guard (FDA 510(k) Clearance)

K202465 · 3D Diagnostix, Inc. · Dental device
Nov 2020
Decision
90d
Days
-
Risk

K202465 is an FDA 510(k) clearance for the Night Guard. This device is classified as a Mouthguard, Prescription.

Submitted by 3D Diagnostix, Inc. (Allston, US). The FDA issued a Cleared decision on November 25, 2020, 90 days after receiving the submission on August 27, 2020.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number K202465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2020
Decision Date November 25, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQC - Mouthguard, Prescription
Device Class -