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

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.

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