510(k) · Cleared

Cleared

SleepRight Select-Comfort Dental Guard

K212767510(k) TraditionalCleared Dec 22, 2021113-day reviewClass U

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

Splintek, Inc. · MQC Mouthguard, Prescription

Cleared on Dec 22, 2021 as substantially equivalent to K071404 (Power Products, Inc.-Splintek, 2007) and 1 other predicate after a 113-day review. Its family tree reaches back 2 generations to 2007.

Decided: Dec 22, 2021
Review: 113 days
Class: Class U
Product code: MQC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K071404 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK071404 Sleep Right - Select, Low Profile and AdvancePower Products, Inc.-Splintek · 2007
1 generation backK100545 SleeprightPower Products, Inc.-Splintek · 2010
This deviceK212767 SleepRight Select-Comfort Dental GuardSplintek, Inc. · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K071404	Sleep Right - Select, Low Profile and Advance	Power Products, Inc.-Splintek	2007	—
−1	K100545	Sleepright	Power Products, Inc.-Splintek	2010	—
0 (this device)	K212767	SleepRight Select-Comfort Dental Guard	Splintek, Inc.	2021	—

FIG. 1 — Lineage of K212767, 2007–2021Source: 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 MQC? 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 MQC device

#1 K203000 KeyPrint KeySplint Hardscore 15.4 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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
*	K071404	Sleep Right - Select, Low Profile and Advance Summary page 5 …Mouthguard Classification Name: Unclassified (OBR, MQC) C. Primary Predicate Device: SleepRight® Low Profile (Splintek Inc., K071404) Reference Device: SleepRight® Original (Splintek Inc., K100545) D. Device Description: The subject…	Power Products, Inc.-Splintek	2007	—
*	K100545	Sleepright Summary page 5 …R, MQC) C. Primary Predicate Device: SleepRight® Low Profile (Splintek Inc., K071404) Reference Device: SleepRight® Original (Splintek Inc., K100545) D. Device Description: The subject device is the second-generation to the SleepRight® Select-Comfort™ Dental Guard…	Power Products, Inc.-Splintek	2010	—

Also cleared against K071404: 8 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 14 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
None of the 2 ancestors has a recall.
8 other devices also cite its predicate K071404.

How does its category compare?

All MQC devices

MQC Mouthguard, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · MQC

4in 2025

2007high 8 (2024) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQC

185in 2025

2007high 286 (2019) · low 79 (2007)2026

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

Recalls per year · MQC

1in 2023

2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQC

7in 2025

2007high 137 (2022) · low 0 (2012)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	79	0	9
2008	0	—	0	6
2009	2	—	0	3
2010	1	—	0	5
2011	4	194	0	2
2012	2	—	0	0
2013	1	—	0	6
2014	1	—	0	2
2015	3	234	0	5
2016	0	—	0	9
2017	2	—	0	7
2018	0	—	0	71
2019	5	286	0	62
2020	4	204	0	46
2021	7	158	0	111
2022	5	120	0	137
2023	6	230	1	62
2024	8	249	0	8
2025	4	185	0	7
2026	2	—	0	—

What is it indicated for?

The SleepRight@ Select-Comfortm Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The SleepRight@ Select-Comfortm Dental Guard is indicated for the protection against teeth grinding, bruxism, and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K212767 · printed Nov 4, 2026

Cite this page

510(k) Report. “K212767: SleepRight Select-Comfort Dental Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212767

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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