Cleared Traditional

K202465 - Night Guard

K202465 · 3D Diagnostix, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2020
Decision
90d
Days
-
Risk

K202465 is an FDA 510(k) clearance for the Night Guard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by 3D Diagnostix, Inc. (Allston, US). The FDA issued a Cleared decision on November 25, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all 3D Diagnostix, Inc. devices

FDA 510(k) Submission Details - K202465

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 56
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K202465.
Panthera Occlusal Appliance
K203596 · Panthera Dental, Inc. · Apr 2021
KeyPrint KeySplint Hard
K203000 · Mycone Dental Supply Co. Inc. (Dba Keystone Industries) · Apr 2021
E-Guard
K201173 · Envisiontec GmbH · Nov 2020
V-Print splint
K201091 · Voco GmbH · Nov 2020
Thermoforming Sheet Materials
K200125 · Erkodent Erich Kopp GmbH · Oct 2020
Ceramill A-Splint
K191836 · Amann Girrbach AG · Dec 2019