Cleared Traditional

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

K202465 · 3D Diagnostix, Inc. · Dental device
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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

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
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.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
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