510(k) · Cleared
ClearedProtect-It Custom Fit Dental Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Doc Brands, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Oct 7, 2022 as substantially equivalent to K151149 (Den Tek Oral Care, Inc., 2015) after a 57-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Oct 7, 2022
- Review
- 57 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022809 (2003). 8 ancestors in all, the oldest K010876 (2001). No later device cites it as a predicate yet.
- 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 backK082301 Grind NO MorePlacontrol, Inc. · 2008
- 1 generation backK151149 Ready-FitDen Tek Oral Care, Inc. · 2015
- This deviceK222424 Protect-It Custom Fit Dental GuardDoc Brands, Inc. · 2022
View 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 | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| −1 | K151149 | Ready-Fit | Den Tek Oral Care, Inc. | 2015 | — |
| 0 (this device) | K222424 | Protect-It Custom Fit Dental Guard | Doc Brands, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 | Decided |
|---|---|---|---|
| * | K151149 | Ready-FitSummary page 4…Guard Applicant: DenTek Oral Care, Inc. Classification Name: Mouthguard, Over-the-Counter Regulation Number: N/A Product Code and Class: OBR; unclassified 510(k) Number: K151149 Reference Device – used in device equivalence comparison Trade Name: Custom Comfort Nightguard Version 2 Applicant: DenTek Oral… | 2015 |
| † | K091660 | Custom Comfort Nightguard Version 2 | 2009 |
| † | K150492 | Ora-GUARD Dental Grind Guard | 2016 |
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 19 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K151149.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.
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/K222424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222424: Protect-It Custom Fit 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/K222424
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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