510(k) · Cleared
ClearedGrind NO More
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Placontrol, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Oct 6, 2008 as substantially equivalent to K072147 (Den Tek Oral Care, Inc., 2007) after a 55-day review. Its family tree reaches back 2 generations to 2003. 8 later devices descend from it.
- Decided
- Oct 6, 2008
- Review
- 55 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022809 (2003). 6 ancestors in all, the oldest K010876 (2001). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK022809 EZ Splint & EZ Splint PMPower Products, Inc.-Splintek · 2003
- 1 generation backK072147 Den Tek Comfort Fit NightguardDen Tek Oral Care, Inc. · 2007
- This deviceK082301 Grind NO MorePlacontrol, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK091175 Grind NO More Version 2 and 3Ranir, LLC · 2009
- Descendant · cites it directly · 2 of its ownK151149 Ready-FitDen Tek Oral Care, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK112879 Rest Assured Ready to Wear Nite ProtectorRanir, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK133423 Rest Assured Extra Comfort Nite ProtectorRanir, LLC · 2013
- Descendant · 4 generations on · 0 of its ownK232238 Goyo Mouthpiece SDimedikorea · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K091175Grind NO More Version 2 and 3Ranir, LLC · 2009 · cites it directly4descendants
- K151149Ready-FitDen Tek Oral Care, Inc. · 2015 · cites it directly2descendants
- K112879Rest Assured Ready to Wear Nite ProtectorRanir, LLC · 2012 · 2 generations on2descendants
- K133423Rest Assured Extra Comfort Nite ProtectorRanir, LLC · 2013 · 3 generations on1descendant
- K232238Goyo Mouthpiece SDimedikorea · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022809 | EZ Splint & EZ Splint PM | Power Products, Inc.-Splintek | 2003 | — |
| −1 | K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | 2007 | — |
| 0 (this device) | K082301 | Grind NO More | Placontrol, Inc. | 2008 | — |
| +1 | K091175 | Grind NO More Version 2 and 3 | Ranir, LLC | 2009 | — |
| +1 | K151149 | Ready-Fit | Den Tek Oral Care, Inc. | 2015 | — |
| +2 | K112879 | Rest Assured Ready to Wear Nite Protector | Ranir, LLC | 2012 | — |
| +3 | K133423 | Rest Assured Extra Comfort Nite Protector | Ranir, LLC | 2013 | — |
| +4 | K232238 | Goyo Mouthpiece S | Dimedikorea | 2024 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K072147 | Den Tek Comfort Fit NightguardSummary page 1…Mouthguard, Over-the-Counter Product Code and CFR Provision OBR, unclassified Predicate Device DenTek Oral Care Inc.'s Comfort Fit NightGuard (K072147) Intended Use / Indications for Use Grind No More is indicated for protection against bruxism or nighttime teeth grindin… | 2007 |
What descends from it? (8)
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 5 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K091175 (Ranir, LLC, 2009) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K072147.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Grind No More is indicated for 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 teeth grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082301: Grind NO More.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082301
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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