Cleared Special

K094020 - GRIND NO MORE GENERATION II

K094020 · Ranir, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
27d
Days
-
Risk

K094020 is an FDA 510(k) clearance for the GRIND NO MORE GENERATION II. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Ranir, LLC (Washington, US). The FDA issued a Cleared decision on January 25, 2010 after a review of 27 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 - K094020

510(k) Number K094020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2009
Decision Date January 25, 2010
Days to Decision 27 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
101d faster than avg
Panel avg: 128d · This submission: 27d
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 K094020.
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
REST ASSURED GENERATION II DENTAL PROTECTOR
K091792 · Ranir Corporation · Jul 2009
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
K094020 · GRIND NO MORE GENERATION II
Download PDF FDA Summary Ranir, LLC