Cleared Traditional

KeyPrint KeySplint Soft (K183598) - FDA 510(k) Clearance

K183598 · Keystone Industries · Dental device
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Nov 2019
Decision
324d
Days
-
Risk

K183598 is an FDA 510(k) clearance for the KeyPrint KeySplint Soft. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Keystone Industries (Gibbstown, US). The FDA issued a Cleared decision on November 15, 2019 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Keystone Industries devices

Submission Details

510(k) Number K183598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2018
Decision Date November 15, 2019
Days to Decision 324 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 127d · This submission: 324d
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 K183598.
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The POD
K182820 · Advanced Facialdontics, LLC · Jul 2019
VeriSplint
K190107 · Whip Mix Corporation · Jul 2019
Brux Night Guard
K181361 · Brux Night Guard · Apr 2019