Cleared Special

K091792 - REST ASSURED GENERATION II DENTAL PROTECTOR

K091792 · Ranir Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
21d
Days
-
Risk

K091792 is an FDA 510(k) clearance for the REST ASSURED GENERATION II DENTAL PROTECTOR. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Ranir Corporation (Washington, US). The FDA issued a Cleared decision on July 8, 2009 after a review of 21 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 - K091792

510(k) Number K091792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2009
Decision Date July 08, 2009
Days to Decision 21 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
107d faster than avg
Panel avg: 128d · This submission: 21d
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 K091792.
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
CUSTOM COMFORT NIGHTGUARD VERSION 2
K091660 · Den Tek Oral Care, Inc. · Jun 2009
GRIND NO MORE VERSION 2 AND 3
K091175 · Ranir, LLC · May 2009
CUSTOM COMFORT NIGHTGUARD
K083400 · Den Tek Oral Care, Inc. · Dec 2008
K091792 · REST ASSURED GENERATION II DENTAL PROTECTOR
Download PDF FDA Summary Ranir Corporation