Cleared Special

K112879 - REST ASSURED READY TO WEAR NITE PROTECTOR

K112879 · Ranir, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
119d
Days
-
Risk

K112879 is an FDA 510(k) clearance for the REST ASSURED READY TO WEAR NITE PROTECTOR. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Ranir, LLC (Washington, US). The FDA issued a Cleared decision on January 27, 2012 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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FDA 510(k) Submission Details - K112879

510(k) Number K112879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date January 27, 2012
Days to Decision 119 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

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.