Cleared Traditional

K072968 - STRESSGARD NIGHTGUARD

K072968 · Totalgard Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K072968

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 128d · This submission: 253d
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 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 K072968.
CUSTOM COMFORT NIGHTGUARD
K083400 · Den Tek Oral Care, Inc. · Dec 2008
GRIND NO MORE
K082301 · Placontrol, Inc. · Oct 2008
IMPROVED COMFORT-FIT NIGHTGUARD
K081669 · Den Tek Oral Care, Inc. · Jul 2008
GRIND GUARD
K073446 · Archtek, Inc. · Feb 2008
THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT
K073220 · Prestige Brands, Inc. · Dec 2007
DEN TEK COMFORT FIT NIGHTGUARD
K072147 · Den Tek Oral Care, Inc. · Aug 2007
K072968 · STRESSGARD NIGHTGUARD
Download PDF FDA Summary Totalgard Corporation