Cleared Traditional

Ready-Fit

K151149 · Den Tek Oral Care, Inc. · Dental
Sep 2015
Decision
153d
Days
—
Risk

About This 510(k) Submission

K151149 is an FDA 510(k) clearance for the Ready-Fit, a Mouthguard, Over-the-counter, submitted by Den Tek Oral Care, Inc. (Maryville, US). The FDA issued a Cleared decision on September 30, 2015, 153 days after receiving the submission on April 30, 2015. This device falls under the Dental review panel.

Submission Details

510(k) Number K151149 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2015
Decision Date September 30, 2015
Days to Decision 153 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code OBR — Mouthguard, Over-the-counter
Device Class —
Definition To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.