Cleared Traditional

STRESSGARD NIGHTGUARD (K072968) - FDA 510(k) Clearance

K072968 · Totalgard Corporation · Dental device

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Jul 2008

Decision

253d

Days

Risk

K072968 is an FDA 510(k) clearance for the STRESSGARD NIGHTGUARD. Classified as Mouthguard, Over-the-counter (product code OBR).

Submitted by Totalgard Corporation (Melrose, US). The FDA issued a Cleared decision on July 1, 2008 after a review of 253 days - an extended review 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: 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 Totalgard Corporation devices

Submission Details

510(k) Number	K072968 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 22, 2007
Decision Date	July 01, 2008
Days to Decision	253 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

126d slower than avg

Panel avg: 127d · This submission: 253d

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

All 44

Devices cleared under the same product code (OBR) and FDA review panel - the closest regulatory comparables to K072968.

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Owl Night Guard

K253641 · Owl Dental Lab, Inc. · Feb 2026

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K252004 · Encore Guards · Nov 2025

Remi Custom Night Guard

K251778 · Remi · Oct 2025

Dentemp Pro-Comfort Dental Guard

K250456 · Doc Brands, Inc. · May 2025

Anti Grinding Guard

K240810 · Xiamen Yizhou Imp. & Exp. Co., Ltd. · May 2024

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K072968

Totalgard Corporation

Melrose, MA · US

LOUIS P IZZI

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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