510(k) · Cleared
Recalled · Class II · 2026Silent Nite sl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · LRK Device, Anti-Snoring
Cleared on Jul 17, 2019 as substantially equivalent to K083209 (Specialty Appliance Works, Inc., 2009) after a 236-day review. Its family tree reaches back 2 generations to 2007. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 17, 2019
- Review
- 236 days
- Class
- Class II
- Product code
- LRK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070327 (2007). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK070327 Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch…Sybron Dental Specialties, Inc. · 2007
- 1 generation backK083209 Acrylic Herbst Splint ApplianceSpecialty Appliance Works, Inc. · 2009
- This deviceK183270 Silent Nite slPrismatik Dentalcraft, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK211069 EndSnorZ Sleep AppliancePrismatik Dentalcraft, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK210694 Silent Nite Sleep Appliance with the Glidewell HingePrismatik Dentalcraft, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK240427 airVata™Gelb Practice Solutions, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK233434 Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K211069EndSnorZ Sleep AppliancePrismatik Dentalcraft, Inc. · 2021 · cites it directly1descendant
- K210694Silent Nite Sleep Appliance with the Glidewell HingePrismatik Dentalcraft, Inc. · 2021 · cites it directly1descendant
- K240427airVata™Gelb Practice Solutions, Inc. · 2024 · 2 generations on0descendants
- K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)Prismatik Dentalcraft, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator | Sybron Dental Specialties, Inc. | 2007 | — |
| −1 | K083209 | Acrylic Herbst Splint Appliance | Specialty Appliance Works, Inc. | 2009 | — |
| 0 (this device) | K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | 2019 | — |
| +1 | K211069 | EndSnorZ Sleep Appliance | Prismatik Dentalcraft, Inc. | 2021 | — |
| +1 | K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | 2021 | — |
| +2 | K240427 | airVata™ | Gelb Practice Solutions, Inc. | 2024 | — |
| +2 | K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) | Prismatik Dentalcraft, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K083209 | Acrylic Herbst Splint ApplianceSummary page 5…8- 1 - | P a g e C. IDENTIFICATION OF PREDICATE DEVICE Primary Predicate: OASYS Hinge ApplianceTM (K083209) Reference Predicate Device: SilentNite® (K972424) D. DEVICE DESCRIPTION Silent Nite® sl is a mandibular advancem… | 2009 |
| * | — | SilentNite Named without a submission number | |
| † | K972424 | Silentnite | 1997 |
What descends from it? (4)
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)
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211069 (Prismatik Dentalcraft, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K083209.
How does its category compare?
All LRK devicesLRK Device, Anti-Snoring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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?
Silent Nite® sl is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. Silent Nite® sl is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
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/K183270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183270: Silent Nite sl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183270
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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