Cleared Special

K112879 - REST ASSURED READY TO WEAR NITE PROTECTOR

K112879 · Ranir, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
9d faster than avg
Panel avg: 128d · 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.

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 K112879.
PROTECH DENT
K121272 · Akervall Technologies, Inc. · Oct 2012
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326 · Oralabs, Inc. · Jun 2012
REST ASSURED GENERATION III DENTAL PROTECTOR
K120103 · Ranir, LLC · Feb 2012
BRUX MOUTHGUARDS
K111310 · Dental Arte, Inc. · Dec 2011
SLEEPRIGHT
K100545 · Power Products, Inc.-Splintek · Jun 2010
GRIND NO MORE GENERATION II
K094020 · Ranir, LLC · Jan 2010
K112879 · REST ASSURED READY TO WEAR NITE PROTECTOR
Download PDF FDA Summary Ranir, LLC