510(k) · Cleared
ClearedSleepRight 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 Jun 1, 2020 as substantially equivalent to K172223 (Splintek, Inc., 2017) and 1 other predicate after a 161-day review. Its family tree reaches back 4 generations to 2003. 2 later devices descend from it.
- Decided
- Jun 1, 2020
- Review
- 161 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K022809 (2003). 9 ancestors in all, the oldest K010876 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 3 generations backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 2 generations backK121272 Protech DentAkervall Technologies, Inc. · 2012
- 1 generation backK172223 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017
- This deviceK193577 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK250743 Remvia NightGuardRemvia · 2025
- Descendant · cites it directly · 0 of its ownK212706 SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom…Splintek, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −3 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −2 | K121272 | Protech Dent | Akervall Technologies, Inc. | 2012 | — |
| −1 | K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017 | — |
| 0 (this device) | K193577 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2020 | — |
| +1 | K250743 | Remvia NightGuard | Remvia | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K172223 | SleepRight ProRx Custom Dental GuardSummary page 5…me: Unclassified (OBR, MQC) C. Primary Predicate Device: SleepRight® ProRx™ Custom Dental Guard (Splintek, Inc., K172223) Reference Predicate Device: ProTech Dent® (Akervall Technologies, K121272) D. Device Description: The SleepRi… | 2017 |
| * | K121272 | Protech DentSummary page 5…ht® ProRx™ Custom Dental Guard (Splintek, Inc., K172223) Reference Predicate Device: ProTech Dent® (Akervall Technologies, K121272) D. Device Description: The SleepRight® ProRx® Custom Dental Guard (K193577) is the second-generation guard to the… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 muscle
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193577: SleepRight ProRx Custom 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/K193577
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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