510(k) · Cleared
ClearedReady-Fit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Den Tek Oral Care, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Sep 30, 2015 as substantially equivalent to K082301 (Placontrol, Inc., 2008) after a 153-day review. Its family tree reaches back 3 generations to 2003. 2 later devices descend from it.
- Decided
- Sep 30, 2015
- Review
- 153 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022809 (2003). 7 ancestors in all, the oldest K010876 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 2 generations backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- 1 generation backK082301 Grind NO MorePlacontrol, Inc. · 2008
- This deviceK151149 Ready-FitDen Tek Oral Care, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK222424 Protect-It Custom Fit Dental GuardDoc Brands, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK202974 DenTek Fresh Protect Dental GuardMedtech Products, Inc. · 2020
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 |
|---|---|---|---|---|---|
| −3 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −2 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| −1 | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| 0 (this device) | K151149 | Ready-Fit | Den Tek Oral Care, Inc. | 2015 | — |
| +1 | K222424 | Protect-It Custom Fit Dental Guard | Doc Brands, Inc. | 2022 | — |
| +1 | K202974 | DenTek Fresh Protect Dental Guard | Medtech Products, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K082301 | Grind NO MoreSummary page 4…te Device Trade Name: Grind No More Applicant: Placontrol Inc. Classification Name: Mouthguard, Over-the-Counter Product Code and Class: OBR; unclassified 510(k) Number: K082301 Device Description Ready-Fit Disposable Dental Guard is a ready-to-wear, posterior-only occlusive mouthguard, with two molar b… | 2008 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K222424 (Doc Brands, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082301.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151149: Ready-Fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151149
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