510(k) · Cleared
ClearedThe Doctor's Nightguard Advanced Comfort
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prestige Brands, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Dec 19, 2007 as substantially equivalent to K053580 (Dental Concepts, LLC, 2006) and 1 other predicate after a 34-day review. Its family tree reaches back 3 generations to 1989. 17 later devices descend from it.
- Decided
- Dec 19, 2007
- Review
- 34 days
- Class
- Class U
- Product code
- OBR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K882303 (1989). 6 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK882303 H&M Anti-Snoring DeviceHays & Meade, Inc. · 1989
- 2 generations backK014079 DR. Hays Bite GuardInventive Resources, Inc. · 2002
- 1 generation backK024261 Dental ProtectorDental Concepts, LLC · 2003
- This deviceK073220 The Doctor's Nightguard Advanced ComfortPrestige Brands, Inc. · 2007
- Descendant · cites it directly · 10 of its ownK082723 GrindguardGrind Guard Technologies, LLC · 2009
- Descendant · 2 generations on · 9 of its ownK123161 Smartguard Night Guard, Smartguard Original, Smartguard Night Guard…Smartguard, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK133037 GrindguardGrind Guard Technologies, LLC · 2014
- Descendant · 3 generations on · 5 of its ownK181099 Bright GuardKoncept Innovators, LLC · 2019
- Descendant · cites it directly · 5 of its ownK091792 Rest Assured Generation II Dental ProtectorRanir Corporation · 2009
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K082723GrindguardGrind Guard Technologies, LLC · 2009 · cites it directly10descendants
- K123161Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original, Smartguard…Smartguard, Inc. · 2013 · 2 generations on9descendants
- K133037GrindguardGrind Guard Technologies, LLC · 2014 · 2 generations on6descendants
- K181099Bright GuardKoncept Innovators, LLC · 2019 · 3 generations on5descendants
- K091792Rest Assured Generation II Dental ProtectorRanir Corporation · 2009 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K882303 | H&M Anti-Snoring Device | Hays & Meade, Inc. | 1989 | — |
| −2 | K014079 | DR. Hays Bite Guard | Inventive Resources, Inc. | 2002 | — |
| −1 | K024261 | Dental Protector | Dental Concepts, LLC | 2003 | — |
| 0 (this device) | K073220 | The Doctor's Nightguard Advanced Comfort | Prestige Brands, Inc. | 2007 | — |
| +1 | K082723 | Grindguard | Grind Guard Technologies, LLC | 2009 | — |
| +2 | K123161 | Smartguard Night Guard, Smartguard Original, Smartguard Night Guard Original… | Smartguard, Inc. | 2013 | — |
| +2 | K133037 | Grindguard | Grind Guard Technologies, LLC | 2014 | — |
| +3 | K181099 | Bright Guard | Koncept Innovators, LLC | 2019 | — |
| +1 | K091792 | Rest Assured Generation II Dental Protector | Ranir Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K053580 | Doctor's NightguardSummary page 1…. Devices to Which Substantial Equivalence is Claimed: Primary Predicate Device: Dental Concepts The Doctor's® NightGuard TM Classic TM (K053580) Secondary Predicate Device: Dental Concepts BruxGuard TM (K024261) 4. Device Description and Technological Characteristics:… | 2006 |
| * | K024261 | Dental ProtectorSummary page 1…dicate Device: Dental Concepts The Doctor's® NightGuard TM Classic TM (K053580) Secondary Predicate Device: Dental Concepts BruxGuard TM (K024261) 4. Device Description and Technological Characteristics: The Doctor's® NightGuard TM Advanced ComfortTM is composed of a sof… | 2003 |
What descends from it? (17)
See all 173 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 18 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K082723 (Grind Guard Technologies, LLC, 2009) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K053580.
How does its category compare?
All OBR devicesOBR Mouthguard, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Doctor's® NightGuard™ Advanced Comfort™ 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 grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073220: The Doctor's Nightguard Advanced Comfort.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073220
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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