510(k) Report

510(k) · Cleared

Cleared

Stressgard Nightguard

K072968510(k) TraditionalCleared Jul 1, 2008253-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Totalgard Corporation · OBR Mouthguard, Over-The-Counter

Cleared on Jul 1, 2008 as substantially equivalent to K053580 (Dental Concepts, LLC, 2006) and 2 other predicates after a 253-day review. Its family tree reaches back 2 generations to 2003.

Decided
Jul 1, 2008
Review
253 days
Class
Class U
Product code
OBR
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K022809 (2003). 7 ancestors in all, the oldest K010876 (2001). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 2 other ancestors2006: 1 other ancestor2001: 1 other ancestorK022809 · EZ Splint & EZ Splint PM · Power Products, Inc.-Splintek · 2003K072147 · Den Tek Comfort Fit Nightguard · Den Tek Oral Care, Inc. · 2007200020022004200620082010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors K072147 · Den Tek Comfort Fit Nightguard · Den Tek Oral Care, Inc. · 2007K022809 · EZ Splint & EZ Splint PM · Power Products, Inc.-Splintek · 20030
  1. Root · 2 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
  2. 1 generation backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
  3. This deviceK072968 Stressgard NightguardTotalgard Corporation · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K022809EZ Splint & EZ Splint PMPower Products, Inc.-Splintek2003—
−1K072147Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc.2007—
0 (this device)K072968Stressgard NightguardTotalgard Corporation2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200610
200720
FIG. 1 — Lineage of K072968, 2003–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OBR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OBR device

  1. #1 K251778 Remi Custom Night Guardscore 15.6 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K053580Doctor's Nightguard
Summary page 2
…0(K) NUMBER: IV COMMON OR USUAL NAME Dental Protector Nightguard V PREDICATE DEVICES Dental Concepts, LLC, The Doctor's® NightguardTM (K053580) Dentek Oral Care, Inc., Comfort Fit Nightguard (K072147) Splintek-Power Products, Inc., SleepRight® (K071404) VI…
Dental Concepts, LLC2006—
*K072147Den Tek Comfort Fit Nightguard
Summary page 2
…tor Nightguard V PREDICATE DEVICES Dental Concepts, LLC, The Doctor's® NightguardTM (K053580) Dentek Oral Care, Inc., Comfort Fit Nightguard (K072147) Splintek-Power Products, Inc., SleepRight® (K071404) VI INTENDED USE/INDICATIONS FOR USE The StressgardTM Ni…
Den Tek Oral Care, Inc.2007—
*K071404Sleep Right - Select, Low Profile and Advance
Summary page 2
…al Concepts, LLC, The Doctor's® NightguardTM (K053580) Dentek Oral Care, Inc., Comfort Fit Nightguard (K072147) Splintek-Power Products, Inc., SleepRight® (K071404) VI INTENDED USE/INDICATIONS FOR USE The StressgardTM Night Guard is indicated for protection from night-time teeth…
Power Products, Inc.-Splintek2007—

Also cleared against K053580: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
  • None of the 7 ancestors has a recall.
  • 7 other devices also cite its predicate K053580.

How does its category compare?

All OBR devices

OBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · OBR

3in 2025

2007: 22008: 52009: 32010: 22011: 12012: 42013: 22014: 22015: 12016: 12017: 12018: 22019: 32020: 32021: 22022: 22023: 12024: 22025: 32026 (partial year): 4
2007high 5 (2008) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBR

129in 2025

2008: 55 days median2009: 16 days median2012: 145 days median2019: 266 days median2020: 161 days median2025: 129 days median2026 (partial year): 103 days median
2007high 266 (2019) · low 16 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OBR

No recall names OBR since 2007.

Adverse event reports per year · OBR

13in 2025

2007: 12009: 72010: 32012: 42013: 82014: 7762015: 312016: 162017: 242018: 232019: 292020: 152021: 102022: 62023: 52024: 182025: 13
2007high 776 (2014) · low 0 (2008)2025

MAUDE reports naming product code OBR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
200855500
200931607
20102—03
20111—00
2012414504
20132—08
20142—0776
20151—031
20161—016
20171—024
20182—023
20193266029
20203161015
20212—010
20222—06
20231—05
20242—018
20253129013
202641030—

What is it indicated for?

The StressgardTM Night Guard is indicated for protection from night-time teeth grinding, clenching and bruxism. It is intended to reduce damage to teeth and to prevent the noise associated with teeth grinding or bruxing.

Indications for use as stated in the FDA summary.

Also cleared against K053580

7 other devices cite the same predicate.

  • K121365Thermoformed MouthguardsGlidewell Laboratories-Sleep Devices Group · 2012
  • K073446Grind GuardArchtek, Inc. · 2008
  • K073220The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
  • K061122Night GuardAlpine Oral Care, LLC · 2007
  • K063483Den Tek NightguardDen Tek Oral Care, Inc. · 2007
  • K063229Rest Assured Nite ProtectorRanir, LLC · 2006

Recent decisions in OBR

The OBR category page

  • K262559Mouth GuardChangSha ChuangDuoLe E-Commerce Co., Ltd. · 2026
  • K260790G-Series Grind GuardASESSO HEALTH, Inc. · 2026
  • K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media Limited · 2026
  • K253641Owl Night GuardOwl Dental Lab, Inc. · 2026
  • K252004enCore Night GuardEncore Guards · 2025

https://510kreport.com/device/K072968 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072968: Stressgard Nightguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072968

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026