Cleared Traditional

K183598 - KeyPrint KeySplint Soft

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

FDA 510(k) Submission Details - K183598

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.

MQC Device Classification - Class 0,

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 42
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K183598.
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