Cleared Traditional

KeyPrint KeySplint Hard (K203000) - FDA 510(k) Clearance

K203000 · Mycone Dental Supply Co. Inc. (Dba Keystone Industries) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
190d
Days
-
Risk

K203000 is an FDA 510(k) clearance for the KeyPrint KeySplint Hard. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Mycone Dental Supply Co. Inc. (Dba Keystone Industries) (Gibbstown, US). The FDA issued a Cleared decision on April 9, 2021 after a review of 190 days - an extended review cycle.

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 Mycone Dental Supply Co. Inc. (Dba Keystone Industries) devices

Submission Details

510(k) Number K203000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2020
Decision Date April 09, 2021
Days to Decision 190 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
63d slower than avg
Panel avg: 127d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 40
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K203000.
LuxaPrint Ortho Plus
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JS Dental Lab Mouth Guard
K210011 · Ampower Dental Laboratories, LLC · Jul 2021
Panthera Occlusal Appliance
K203596 · Panthera Dental, Inc. · Apr 2021
E-Guard
K201173 · Envisiontec GmbH · Nov 2020
Night Guard
K202465 · 3D Diagnostix, Inc. · Nov 2020
V-Print splint
K201091 · Voco GmbH · Nov 2020