Cleared Special

K120103 - REST ASSURED GENERATION III DENTAL PROTECTOR (FDA 510(k) Clearance)

K120103 · Ranir, LLC · Dental device
Download Printable Device Report (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.

View all Ranir, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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