Cleared Special

K133423 - REST ASSURED EXTRA COMFORT NITE PROTECTOR

K133423 · Ranir, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
42d
Days
-
Risk

K133423 is an FDA 510(k) clearance for the REST ASSURED EXTRA COMFORT NITE PROTECTOR. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Ranir, LLC (Grand Rapids, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 42 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K133423

510(k) Number K133423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2013
Decision Date December 20, 2013
Days to Decision 42 days
Submission Type Special
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
86d faster than avg
Panel avg: 128d · This submission: 42d
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 K133423.
Ready-Fit
K151149 · Den Tek Oral Care, Inc. · Sep 2015
THE BITE GUARD
K132469 · International Profit Builders, Inc. · Feb 2014
GRINDGUARD
K133037 · Grind Guard Technologies, LLC · Jan 2014
NEW COMFORT-FIT DENTAL GUARD
K123849 · Den Tek Oral Care, Inc. · Jan 2013
PROTECH DENT
K121272 · Akervall Technologies, Inc. · Oct 2012
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD
K113326 · Oralabs, Inc. · Jun 2012
K133423 · REST ASSURED EXTRA COMFORT NITE PROTECTOR
Download PDF FDA Summary Ranir, LLC