Cleared Traditional

K063229 - REST ASSURED NITE PROTECTOR (FDA 510(k) Clearance)

K063229 · Ranir, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
55d
Days
-
Risk

K063229 is an FDA 510(k) clearance for the REST ASSURED 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 19, 2006 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ranir, LLC devices

Submission Details

510(k) Number K063229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2006
Decision Date December 19, 2006
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

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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