Cleared Traditional

K191033 - LunaGuard Nighttime Dental Protector

K191033 · Mckeon Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
109d
Days
-
Risk

K191033 is an FDA 510(k) clearance for the LunaGuard Nighttime Dental Protector. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Mckeon Products (Warren, US). The FDA issued a Cleared decision on August 5, 2019 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Mckeon Products devices

FDA 510(k) Submission Details - K191033

510(k) Number K191033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2019
Decision Date August 05, 2019
Days to Decision 109 days
Submission Type Traditional
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
18d faster than avg
Panel avg: 127d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

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 Consultant

Right Submission, LLC
Elizabeth FitzGerald

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OBR Mouthguard, Over-the-counter

All 19
Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K191033.
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ClenchGuard
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CustMBite Dental Guard
K183315 · Dental Choice Holdings, LLC · Aug 2019
Bright Guard
K181099 · Koncept Innovators, LLC · Jan 2019
DenTek Ultimate Dental Guard
K180933 · Medtech Products, Inc. · Sep 2018
Bruxor
K172452 · Sleep Specialties, LLC · Jan 2018