510(k) · Cleared
ClearedProtech Dent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akervall Technologies, Inc. · OBR Mouthguard, Over-The-Counter
Cleared on Oct 15, 2012 as substantially equivalent to K072147 (Den Tek Oral Care, Inc., 2007) after a 171-day review. Its family tree reaches back 2 generations to 2003. 5 later devices descend from it.
- Decided
- Oct 15, 2012
- Review
- 171 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). 5 later devices descend from it, 3 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 deviceK121272 Protech DentAkervall Technologies, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK172223 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK193577 SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK250743 Remvia NightGuardRemvia · 2025
- Descendant · 2 generations on · 0 of its ownK212706 SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom…Splintek, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK191033 LunaGuard Nighttime Dental ProtectorMckeon Products · 2019
Most influential descendants
Showing 5 of 5 · See all- K172223SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017 · cites it directly3descendants
- K193577SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020 · cites it directly2descendants
- K250743Remvia NightGuardRemvia · 2025 · 2 generations on0descendants
- K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2021 · 2 generations on0descendants
- K191033LunaGuard Nighttime Dental ProtectorMckeon Products · 2019 · cites it directly0descendants
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) | K121272 | Protech Dent | Akervall Technologies, Inc. | 2012 | — |
| +1 | K172223 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2017 | — |
| +1 | K193577 | SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2020 | — |
| +2 | K250743 | Remvia NightGuard | Remvia | 2025 | — |
| +2 | K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | Splintek, Inc. | 2021 | — |
| +1 | K191033 | LunaGuard Nighttime Dental Protector | Mckeon Products | 2019 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (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…sified (Pre Amendment) Classification Name: Mouthguard; OBR, Common/Usual Name: Mouthiguard, Over-the-Counter 2. Equivalent legally marketed devices: OBR: K 072147 DenTek Comfort Fit NightGuard 3: Intended Use: The Akervall Technologies mouthiguards (ProTech Dent, are indicated for use in p… | 2007 |
What descends from it? (5)
3 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 9 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K172223 (Splintek, Inc., 2017) has gone furthest, with 3 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. 2012, 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 Akervall Technologies mouthguards (ProTech Dent, are indicated for use in protecting the teeth and reduce damage caused by bruxism or nighttime grinding.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121272: Protech Dent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121272
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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