510(k) · Cleared
ClearedSleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Splintek, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Dec 13, 2021 as substantially equivalent to K193577 (Splintek, Inc., 2020) and 1 other predicate after a 109-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Dec 13, 2021
- Review
- 109 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K022809 (2003). 10 ancestors in all, the oldest K010876 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 4 generations backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 3 generations backK121272 Protech DentAkervall Technologies, Inc. · 2012
- 2 generations backK172223 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017
- 1 generation backK193577 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020
- This deviceK212706 SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom…Splintek, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −4 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −3 | K121272 | Protech Dent | Akervall Technologies, Inc. | 2012 | — |
| −2 | K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017 | — |
| −1 | K193577 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2020 | — |
| 0 (this device) | K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K193577 | SleepRight ProRx Custom Dental GuardSummary page 7…ame: Unclassified (OBR, MQC) C. Primary Predicate Device: SleepRight® ProRx® Custom Dental Guard (Splintek Inc., K193577) Reference Predicate Device: SleepRight® ProRx™ Custom Dental Guard (Splintek Inc.,… | 2020 |
| * | K172223 | SleepRight ProRx Custom Dental GuardSummary page 7…K193577) Reference Predicate Device: SleepRight® ProRx™ Custom Dental Guard (Splintek Inc., K172223) D. Device Description: The subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRi… | 2017 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 10 ancestors has a recall.
- 1 other device also cites its predicate K193577.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OBR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBR
129in 2025
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 5 | 55 | 0 | 0 |
| 2009 | 3 | 16 | 0 | 7 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 4 | 145 | 0 | 4 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 776 |
| 2015 | 1 | — | 0 | 31 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 24 |
| 2018 | 2 | — | 0 | 23 |
| 2019 | 3 | 266 | 0 | 29 |
| 2020 | 3 | 161 | 0 | 15 |
| 2021 | 2 | — | 0 | 10 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 3 | 129 | 0 | 13 |
| 2026 | 4 | 103 | 0 | — |
What is it indicated for?
* Protection against bruxism or nighttime teeth grinding * Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding * Protection against teeth grinding, bruxism, and jaw clenching * Short-term pain relief from muscle spasm due to occlusal interference * 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…
Read the full statement (142 words)
* Protection against bruxism or nighttime teeth grinding
* Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding
* Protection against teeth grinding, bruxism, and jaw clenching
* Short-term pain relief from muscle spasm due to occlusal interference
* 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
* Protection against bruxism or nighttime teeth grinding
* Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding
* Protection against teeth grinding, bruxism, and jaw clenching
* Short-term pain relief from muscle spasm due to occlusal interference
* 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/K212706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212706: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212706
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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