510(k) · Cleared
ClearedSleepbite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dental Imagineers, LLC · LRK Device, Anti-Snoring
Cleared on Jan 30, 2002 as substantially equivalent to K971794 (Frantz Design, Inc., 1997) and 1 other predicate after a 76-day review. Its family tree reaches back 2 generations to 1988. 11 later devices descend from it.
- Decided
- Jan 30, 2002
- Review
- 76 days
- Class
- Class II
- Product code
- LRK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K880956 (1988). 4 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK880956 Snoar (TM) Open Airway ApplianceKent J. Toone, D.D.S. · 1988
- 1 generation backK971794 Elastic Mandibular Advancement (Ema) ApplianceFrantz Design, Inc. · 1997
- This deviceK013808 SleepbiteDental Imagineers, LLC · 2002
- Descendant · cites it directly · 9 of its ownK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- Descendant · cites it directly · 8 of its ownK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
- Descendant · 2 generations on · 7 of its ownK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- Descendant · 3 generations on · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
- Descendant · 4 generations on · 3 of its ownK182312 Zyppah Anti-Snoring DeviceAlways More Marketing · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005 · cites it directly9descendants
- K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006 · cites it directly8descendants
- K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009 · 2 generations on7descendants
- K111680DR. Greensburg's HybridAlways More Marketing, Inc. · 2011 · 3 generations on6descendants
- K182312Zyppah Anti-Snoring DeviceAlways More Marketing · 2019 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880956 | Snoar (TM) Open Airway Appliance | Kent J. Toone, D.D.S. | 1988 | — |
| −1 | K971794 | Elastic Mandibular Advancement (Ema) Appliance | Frantz Design, Inc. | 1997 | — |
| 0 (this device) | K013808 | Sleepbite | Dental Imagineers, LLC | 2002 | — |
| +1 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| +1 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
| +2 | K091035 | Full Breath Sleep Appliance Lower (FBSL) | Bryan Keropian Dds | 2009 | — |
| +3 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
| +4 | K182312 | Zyppah Anti-Snoring Device | Always More Marketing | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 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 LRK? 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 LRK device
- #1 K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for…score 16.3 · 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 |
|---|---|---|---|
| * | K971794 | Elastic Mandibular Advancement (Ema) Appliance Our OCR of the scanned summary read K971724, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Elastic Mandibular Appliance (EMA)”. | 1997 |
| * | K972424 | SilentniteSummary page 1…ance is substantially equivalent to the Elastic Mandibular Appliance, also referred to as EMA, K971724. It is also substantially equivalent to the Silent Nite appliance, K972424. Description: SleepBite is a double plate mandibular advancement device that is adjustable via a calibrated advancement screw. T… | 1997 |
What descends from it? (11)
See all 113 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 14 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K052862 (Bryan Keropian Dds, 2005) has gone furthest, with 9 descendants of its own.
- 9 other devices also cite its predicate K971794.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRK
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LRK
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRK
653in 2025
MAUDE reports naming product code LRK, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 109 | 0 | 1 |
| 2009 | 3 | 88 | 2 | 11 |
| 2010 | 8 | 195 | 0 | 7 |
| 2011 | 10 | 134 | 0 | 69 |
| 2012 | 10 | 142 | 0 | 445 |
| 2013 | 9 | 233 | 0 | 72 |
| 2014 | 11 | 219 | 0 | 49 |
| 2015 | 6 | 117 | 0 | 28 |
| 2016 | 10 | 157 | 0 | 18 |
| 2017 | 7 | 170 | 0 | 32 |
| 2018 | 10 | 200 | 0 | 61 |
| 2019 | 13 | 150 | 0 | 56 |
| 2020 | 5 | 80 | 0 | 24 |
| 2021 | 10 | 126 | 0 | 49 |
| 2022 | 11 | 154 | 0 | 40 |
| 2023 | 5 | 156 | 0 | 50 |
| 2024 | 6 | 254 | 0 | 185 |
| 2025 | 14 | 107 | 1 | 653 |
| 2026 | 10 | 63 | 1 | — |
What is it indicated for?
SleepBite is prescribed for the patient by the healthcare professional.
A. Sleep Bite is indicated for use in patients with benign snoring, when snoring is not accompanied by sleep apnea.
B. Sleep Bite is indicated for use in patients with snoring, when medically prescribed following the appropriate testing for obstructive sleep apnea.
C. Sleep Bite is indicated for patients who suffer from sleep bruxism concomitant with benign snoring.
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/K013808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013808: Sleepbite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013808
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026