Cleared Traditional

K151149 - Ready-Fit

K151149 · Den Tek Oral Care, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
153d
Days
-
Risk

K151149 is an FDA 510(k) clearance for the Ready-Fit. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Den Tek Oral Care, Inc. (Maryville, US). The FDA issued a Cleared decision on September 30, 2015 after a review of 153 days - an extended review cycle.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K151149

510(k) Number K151149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 128d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

OBR Device Classification - Class 0,

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.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 46
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K151149.
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K151149 · Ready-Fit
Download PDF FDA Summary Den Tek Oral Care, In…