510(k) · Cleared
Recalled · Class II · 2026Silentnite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glidewell Laboratories · LRK Device, Anti-Snoring
Cleared on Sep 18, 1997 after an 83-day review. The FDA summary names its predicate without a number. 18 later devices descend from it. It has been recalled once.
- Decided
- Sep 18, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- LRK
- Recalls
- 1
- Predicates
- 0
18 later devices descend from it, 6 citing it directly.
- This deviceK972424 SilentniteGlidewell Laboratories · 1997
- Descendant · cites it directly · 11 of its ownK013808 SleepbiteDental Imagineers, LLC · 2002
- Descendant · 2 generations on · 9 of its ownK052862 Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005
- Descendant · 2 generations on · 8 of its ownK061228 Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006
- Descendant · 3 generations on · 7 of its ownK091035 Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009
- Descendant · cites it directly · 6 of its ownK111680 DR. Greensburg's HybridAlways More Marketing, Inc. · 2011
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K013808SleepbiteDental Imagineers, LLC · 2002 · cites it directly11descendants
- K052862Full Breath Sleep Appliance - AB (Anterior Bite)Bryan Keropian Dds · 2005 · 2 generations on9descendants
- K061228Full Breath Sleep Appliance with Posterior Tongue DepressorBryan Keropian Dds · 2006 · 2 generations on8descendants
- K091035Full Breath Sleep Appliance Lower (FBSL)Bryan Keropian Dds · 2009 · 3 generations on7descendants
- K111680DR. Greensburg's HybridAlways More Marketing, Inc. · 2011 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972424 | Silentnite | Glidewell Laboratories | 1997 | — |
| +1 | K013808 | Sleepbite | Dental Imagineers, LLC | 2002 | — |
| +2 | K052862 | Full Breath Sleep Appliance - AB (Anterior Bite) | Bryan Keropian Dds | 2005 | — |
| +2 | K061228 | Full Breath Sleep Appliance with Posterior Tongue Depressor | Bryan Keropian Dds | 2006 | — |
| +3 | K091035 | Full Breath Sleep Appliance Lower (FBSL) | Bryan Keropian Dds | 2009 | — |
| +1 | K111680 | DR. Greensburg's Hybrid | Always More Marketing, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (7)
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 |
|---|---|---|---|
| * | — | SILENCER by Silent Knights Ventures, Inc. Named without a submission number | |
| * | — | THERASNORE by Dr. Thomas E. Meade Named without a submission number | |
| * | — | PM POSITIONER by Dental Services Group Named without a submission number | |
| * | — | KLEARWAY by Great Lakes Orthodontics Named without a submission number | |
| * | — | SNOREFREE by Space Maintainers Laboratory Named without a submission number | |
| * | — | SNORNOMORE by Annalan Labs Named without a submission number | |
| * | — | “Z” by “Z” Training Named without a submission number |
What descends from it? (18)
See all 186 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2026 | Class II | Z-2769-2026 | Process control | Due to device not having FDA Clearance |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013808 (Dental Imagineers, LLC, 2002) has gone furthest, with 11 descendants of its own.
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?
The SilentNite™ mandibular repositioning (MRP) device is indicated for persons who wish to prevent snoring and is available only from a dentist by prescription. It has been estimated that 6 million or more adults (with men outnumbering women 8 to 1) snores, and that 10% may have sleep apnea. If an examination of the patient, together with the patient’s responses to a questionnaire, indicate the possibility of a more serious sleep disorder than “primary”…
Read the full statement (237 words)
The SilentNite™ mandibular repositioning (MRP) device is indicated for persons who wish to prevent snoring and is available only from a dentist by prescription. It has been estimated that 6 million or more adults (with men outnumbering women 8 to 1) snores, and that 10% may have sleep apnea. If an examination of the patient, together with the patient’s responses to a questionnaire, indicate the possibility of a more serious sleep disorder than “primary” or “social” snoring, the patient should be referred to a physician who can diagnose sleep apnea based on testing in a sleep laboratory and suggest treatment options. Necessary treatment for serious cases of sleep apnea may include surgery, or a medically prescribed treatment called nasal continuous positive airway pressure, or a MRP device. MRP devices may be appropriate treatment for persons with mild sleep apnea swhen surgical and other medical treatments are ineffective or not desired. Contraindications for use: Based on the dentists examination and the patient’s responses the questionnaire, obstructive sleep apnea may either be indicated or cannot be excluded. In such event, an examination by a sleep disorder specialist is recommended before prescribing the SilentNite™ snoring device. If the dentist’s examination and the patient’s responses to the questionnaire indicate the possibility of disease or injury to the mandibular joint, the SilentNite™ snoring device is contraindicated and should not be prescribed, to avoid the possibility of further damage to the mandibular joint.
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/K972424 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972424: Silentnite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972424
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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