Cleared Traditional

Panthera Occlusal Appliance (K203596) - FDA 510(k) Clearance

K203596 · Panthera Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
132d
Days
-
Risk

K203596 is an FDA 510(k) clearance for the Panthera Occlusal Appliance. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Panthera Dental, Inc. (Quebec, CA). The FDA issued a Cleared decision on April 20, 2021 after a review of 132 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 Panthera Dental, Inc. devices

Submission Details

510(k) Number K203596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2020
Decision Date April 20, 2021
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
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