Cleared Traditional

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

K183598 · Keystone Industries · Dental device

Nov 2019

Decision

324d

Days

Risk

K183598 is an FDA 510(k) clearance for the KeyPrint KeySplint Soft. This device is classified as a Mouthguard, Prescription.

Submitted by Keystone Industries (Gibbstown, US). The FDA issued a Cleared decision on November 15, 2019, 324 days after receiving the submission on December 26, 2018.

This device falls under the Dental FDA review panel.

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