510(k) · Cleared

Cleared

Brux Mouthguards

K111310510(k) TraditionalCleared Dec 8, 2011212-day reviewClass U

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

Dental Arte, Inc. · OBR Mouthguard, Over-The-Counter

Cleared on Dec 8, 2011 as substantially equivalent to K073446 (Archtek, Inc., 2008) after a 212-day review. Its family tree reaches back 2 generations to 2006.

Decided: Dec 8, 2011
Review: 212 days
Class: Class U
Product code: OBR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K053580 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK053580 Doctor's NightguardDental Concepts, LLC · 2006
1 generation backK073446 Grind GuardArchtek, Inc. · 2008
This deviceK111310 Brux MouthguardsDental Arte, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K053580	Doctor's Nightguard	Dental Concepts, LLC	2006	—
−1	K073446	Grind Guard	Archtek, Inc.	2008	—
0 (this device)	K111310	Brux Mouthguards	Dental Arte, Inc.	2011	—

FIG. 1 — Lineage of K111310, 2006–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K251778 Remi Custom Night Guardscore 15.6 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K073446	Grind Guard Summary page 1 …@dentalarteinc.com www.dentalarteinc.com DATE PREPARED: October 18, 2011 TRADE OR PROPRIETARY NAME: BRUX MOUTHGUARDS CLASSIFICATION NAME: MOUTH-GUARDS PREDICATE DEVICE: K073446 This summary includes only information that is also covered in the body of this 5 10(k) document, does not contain any puffery o…	Archtek, Inc.	2008	—

Also cleared against K073446: 1 other device →

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 3.8 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K073446.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · OBR

3in 2025

2007high 5 (2008) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBR

129in 2025

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

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

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	1
2008	5	55	0
2009	3	16	7
2010	2	—	3
2011	1	—	0
2012	4	145	4
2013	2	—	8
2014	2	—	776
2015	1	—	31
2016	1	—	16
2017	1	—	24
2018	2	—	23
2019	3	266	29
2020	3	161	15
2021	2	—	10
2022	2	—	6
2023	1	—	5
2024	2	—	18
2025	3	129	13
2026	4	103	—

What is it indicated for?

BRUX MOUTHGUARDS are indicated to help protect the teeth from damage caused by bruxism, sports injuries, and muscle contractions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111310: Brux Mouthguards.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111310

Report an extraction error

Are you the manufacturer?

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