Cleared Special

K120103 - REST ASSURED GENERATION III DENTAL PROTECTOR

K120103 · Ranir, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
22d
Days
-
Risk

K120103 is an FDA 510(k) clearance for the REST ASSURED GENERATION III DENTAL PROTECTOR. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Ranir, LLC (Washington, US). The FDA issued a Cleared decision on February 3, 2012 after a review of 22 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 - K120103

510(k) Number K120103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2012
Decision Date February 03, 2012
Days to Decision 22 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
106d faster than avg
Panel avg: 128d · This submission: 22d
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 K120103.
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
REST ASSURED READY TO WEAR NITE PROTECTOR
K112879 · Ranir, LLC · Jan 2012
BRUX MOUTHGUARDS
K111310 · Dental Arte, Inc. · Dec 2011
SLEEPRIGHT
K100545 · Power Products, Inc.-Splintek · Jun 2010
K120103 · REST ASSURED GENERATION III DENTAL PROTECTOR
Download PDF FDA Summary Ranir, LLC